U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Drug and Biologic Approval and IND Activity Reports
  6. First Generic Drug Approvals
  7. 2018 First Generic Drug Approvals
  1. First Generic Drug Approvals

2018 First Generic Drug Approvals

Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for patients.

“First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States. FDA considers first generics to be important to public health, and prioritizes review of these submissions.

Note: Approved drugs are not always available on or after the listed approval date. Please contact the listed ANDA applicant for more information about a drug product’s availability.

First-Time Generic Drug Approvals 2018*

  ANDA Number Generic Name ANDA Applicant Brand Name ANDA Approval Date ANDA Indication+
99 210618 Hydroxyprogesterone Caproate Injection USP, 1250 mg/5 mL (250 mg/mL) Multi-dose Vials  Slayback Pharma LLC mg/mL  Makena (Hydroxyprogesterone Caproate) Injection, 250 mg/mL 12/28/2018 For reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth
98 209345 Pimecrolimus Cream, 1%  Actavis Laboratories UT, Inc.  Elidel (Pimecrolimus) Cream, 1%  12/27/2018
 
For the second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis
97 208861 Methylphenidate Hydrochloride Extended-Release Capsules, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg  Actavis Elizabeth LLC Aptensio XR (Methylphenidate Hydrochloride) Extended-Release Capsules, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg  12/13/2018 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD)
 
96 208813 Toremifene Citrate Tablets, 60 mg  EirGen Pharma Limited  Fareston (Toremifene Citrate) Tablets, 60 mg   12/4/2018 For the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors
95 204246  Ganirelix Acetate Injection, 250 mcg/ 0.5 mL, Single-Dose Prefilled Syringe Sun Pharmaceutical Industries Ltd. Ganirelix Acetate Injection, 250 mcg/ 0.5 mL, Single-Dose Prefilled Syringe 11/30/2018 For the inhibition of premature LH surges in women undergoing controlled ovarian hyper-stimulation
94 202584 Bismuth Subsalicylate Chewable Tablets, 262.4 mg, Metronidazole Tablets, 250 mg, Tetracycline Hydrochloride Capsules, 500 mg Ailex Pharmaceuticals, LLC Helidac (Bismuth Subsalicylate Chewable Tablets, 262.4 mg, Metronidazole Tablets, 250 mg, Tetracycline Hydrochloride Capsules, 500 mg 11/30/2018 For the eradication of H. pylori for treatment of patients with H. pylori infection and duodenal ulcer disease (active or a history of duodenal ulcer)
93 208678  Colchicine Capsules, 0.6 mg Par Pharmaceutical, Inc.  Mitigare (Colchicine) Capsules, 0.6 mg 11/29/2018 For the prophylaxis of gout flares in adults
 92 208129  Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 80 mcg/ 20 mL, 200 mcg/ 50 mL, 400 mcg/ 100 mL (4 mcg/mL) Single-Dose Containers  Fresenius Kabi USA, LLC  Precedex (Dexmedetomidine Hydrochloride) in 0.9% Sodium Chloride Injection, 80 mcg/ 20 mL, 200 mcg/ 50 mL, 400 mcg/ 100 mL (4 mcg/mL) Single-Dose Containers 11/29/2018 For the sedation of non-intubated patients prior to and/or during surgical and other procedures
91 209060  Aminocaproic Acid Tablets USP, 500 mg, 1000 mg  Sunny Pharmtech Inc  Amicar (Aminocaproic Acid) Tablets, 500 mg, 1000 mg  11/27/2018 For enhancing hemostasis when fibrinolysis contributes to bleeding
90 202142  Oxycodone Hydrochloride and Acetaminophen Oral Solution, 10 mg/ 300 mg per 5 mL Mikart, Inc. Roxicet (Oxycodone Hydrochloride and Acetaminophen) Oral Solution, 5 mg/ 325 mg per 5 mL 11/27/2018 For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate
89 204937 Buprenorphine Transdermal System, 5 mcg/hour, 10 mcg/hour, 15 mcg/hour, 20 mcg/hour Watson Laboratories, Inc. Butrans (Buprenorphine) Transdermal System,   5 mcg/hour, 10 mcg/hour, 15 mcg/hour, 20 mcg/hour 11/20/2018 For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate
88 200480 DycloPro (Dyclonine Hydrochloride) Topical Solution, 0.5%, 1% Novocol, Inc. dba Septodont  Dyclone (Dyclonine Hydrochloride) Topical Solution, 0.5%, 1% 11/20/2018 For anesthetizing accessible mucous membranes (e.g., the mouth, pharynx, larynx, trachea, esophagus, and urethra) prior to various endoscopic procedures
87 208754 Docosanol Cream, 10% (OTC) Actavis Laboratories UT, Inc.  Abreva (Docosanol) Cream, 10% (OTC) 11/19/2018 For the treatment of cold sores/fever blisters on the face or lips; shortens healing time and duration of symptoms
86 208724  Azelaic Acid Gel, 15% Tolmar, Inc  Finacea (Azelaic Acid) Gel , 15% 11/19/2018 For the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea
85 208011 Azelaic Acid Gel, 15% Actavis Laboratories UT, Inc. Finacea (Azelaic Acid) Gel, 15% 11/19/2018 For the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea
84 204637 Azelaic Acid Gel, 15% Glenmark Pharmaceuticals SA  Finacea (Azelaic Acid) Gel, 15% 11/19/2018 For the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea
83 208324  Vardenafil Hydrochloride Orally Disintegrating Tablets, 10 mg Alembic Pharmaceuticals Limited Staxyn (Vardenafil Hydrochloride) Orally Disintegrating Tablets, 10 mg 11/16/2018 For the treatment of erectile dysfunction
82 208453 Abiraterone Acetate Tablets, 250 mg  Apotex, Inc. Zytiga (Abiraterone Acetate) Tablets, 250 mg  10/31/2018 For the treatment of patients with metastatic castration-resistant prostate cancer (CRPC)
81 208446 Abiraterone Acetate Tablets, 250 mg  Mylan Pharmaceuticals, Inc Zytiga (Abiraterone Acetate) Tablets, 250 mg  10/31/2018 For the treatment of patients with metastatic castration-resistant prostate cancer (CRPC)
80 208432  Abiraterone Acetate Tablets, 250 mg Teva Pharmaceuticals USA, Inc. Zytiga (Abiraterone Acetate) Tablets, 250 mg 10/31/2018 For the treatment of patients with metastatic castration-resistant prostate cancer (CRPC)
79 208339 Abiraterone Acetate Tablets, 250 mg  Hikma Pharmaceuticals LLC Zytiga (Abiraterone Acetate) Tablets, 250 mg 10/31/2018 For the treatment of patients with metastatic castration-resistant prostate cancer (CRPC)
78 209726 Naproxen Sodium and Diphenhydramine Hydrochloride Tablets, 220 mg/ 25 mg (OTC) Amneal Pharmaceuticals Company GmbH Aleve PM (Naproxen Sodium and Diphenhydramine Hydrochloride) Tablets, 220 mg/ 25 mg (OTC)  10/23/2018  For the relief of occassional sleeplessness when associated with minor aches and pains
77 211259 Clobazam Oral Suspension, 2.5 mg/mL Mylan Pharmaceuticals Inc. Onfi (Clobazam) Oral Suspension, 2.5 mg/mL 10/22/2018 For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older
76 210569 Clobazam Oral Suspension, 2.5 mg/mL Upsher-Smith Laboratories, LLC Onfi (Clobazam) Oral Suspension, 2.5 mg/mL 10/22/2018  For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older
75  210039  Clobazam Oral Suspension, 2.5 mg/mL Amneal Pharmaceuticals LLC Onfi (Clobazam) Oral Suspension, 2.5 mg/mL 10/22/2018 For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older
74 209715 Clobazam Oral Suspension, 2.5 mg/mL West-Ward Pharmaceuticals International Limited Onfi (Clobazam) Oral Suspension, 2.5 mg/mL 10/22/2018 For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older
73 208819  Clobazam Oral Suspension, 2.5 mg/mL Bionpharma Inc. Onfi (Clobazam) Oral Suspension, 2.5 mg/mL 10/22/2018 For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older
72 211449 Clobazam Tablets, 10 mg, 20 mg Zydus Pharmaceuticals (USA), Inc. Onfi (Clobazam) Tablets, 10 mg, 20 mg 10/22/2018 For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older
71 209808 Clobazam Tablets, 10 mg, 20 mg Piramal Healthcare UK Limited  Onfi (Clobazam) Tablets, 10 mg, 20 mg 10/22/2018 For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older
70 209795  Clobazam Tablets, 10 mg, 20 mg Hetero USA, Inc.  Onfi (Clobazam) Tablets, 10 mg, 20 mg 10/22/2018 For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older
69 209718 Clobazam Tablets, 10 mg, 20 mg Amneal Pharmaceuticals Company GmbH  Onfi (Clobazam) Tablets, 10 mg, 20 mg 10/22/2018 For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older
68 209687 Clobazam Tablets, 10 mg, 20 mg Upsher-Smith Laboratories, LLC  Onfi (Clobazam) Tablets, 10 mg, 20 mg 10/22/2018 For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older 
67 209440  Clobazam Tablets, 10 mg, 20 mg  Taro Pharmaceuticals U.S.A. Inc.  Onfi (Clobazam) Tablets, 10 mg, 20 mg 10/22/2018 For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older 
66 209308 Clobazam Tablets, 10 mg, 20 mg Breckenridge Pharmaceutical, Inc. Onfi (Clobazam) Tablets, 10 mg, 20 mg 10/22/2018 For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older 
65 208825 Clobazam Tablets, 10 mg, 20 mg Bionpharma Inc.  Onfi (Clobazam) Tablets, 10 mg, 20 mg 10/22/2018 For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older
64 208785 Clobazam Tablets, 10 mg, 20 mg  West-Ward Pharmaceuticals Internatonal Limited  Onfi (Clobazam) Tablets, 10 mg, 20 mg 10/22/2018 For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older
63 209148 Adapalene and Benzoyl Peroxide Gel, 0.3%/ 2.5% Taro Pharmaceuticals USA, Inc  Epiduo Forte (Adapalene and Benzoyl Peroxide) Gel,  0.3%/ 2.5% 10/17/2018  For the topical treatment of acne vulgaris
62 207891 Omeprazole Delayed-Release Tablets, 20 mg  Sun Pharmaceutical Industries Limited   Omeprazole Delayed-Release Tablets, 20 mg 10/12/2018  For the treatment of frequent heartburn
61 210574 Cefixime Capsules, 400 mg Alkem Laboratories Limited Suprax (Cefixime) Capsules, 400 mg 10/9/2018 For treatment of adults and children six months and older with Urinary Tract Infections, Pharyngitis, Tonsillitis, Acute Exacerbations of Chronic Bronchitis, and Uncomplicated Gonorrhea (cervical/urethral)
60 207141 Noxivent (Nitric Oxide) Gas for Inhalation, 100 ppm and 800 ppm Praxair Distribution, Inc.  INOmax (Nitric Oxide) Gas for Inhalation, 100 ppm and 800 ppm 10/2/2018 For improved oxygenation and to reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure
59 210434 Albendazole Tablets USP, 200 mg Cipla Limited Albenza (Albendazole) Tablets, 200 mg 9/21/2018 For treatment of parenchymal neurocysticercosis due to active lesion caused by larval forms of the pork tapeworm, Taenia solium
58 210179 Carmustine for Injection USP, 100 mg/vial Navinta LLC. BiCNU (Carmustine) for Injection, 100 mg/vial 9/11/2018  For palliative therapy in certain brain tumors, multiple myeloma, relapsed or refractory Hodgkin's and Non-Hodgkin's lymphoma
57  208390 Ticagrelor Tablets, 60 mg, 90 mg  Watson Laboratories, Inc.  Brilinta (Ticagrelor) Tablets, 60 mg, 90 mg  9/4/2018  For post-acute coronary syndrome (ACS) management 
56  203041 Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate Tablets, 600 mg/200 mg/300 mg Aurobindo Pharma Limited Atripla (Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate) Tablets, 600 mg/200 mg/300 mg 9/4/2018 For the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg
55  208231 Arsenic Trioxide Injection, 10 mg/10 mL (1 mg/mL) Single-dose vial Fresenius Kabi USA, LLC  Trisenox (Arsenic Trioxide) Injection, 10 mg/10 mL (1 mg/mL) Single-dose vial 8/312018  For induction of remission and consolidation in certain patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy
54  090165 Aripiprazole Orally Disintegrating Tablets USP, 20 mg, 30 mg Zydus Pharmaceuticals (USA), Inc.  Abilify (Aripiprazole) DISCMELT Orally Disintegrating Tablets, 20 mg, 30 mg 8/28/2018  For the treatment of Schizophrenia
53  209721 Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 100mg/150mg, 133mg/200mg, 167mg/250mg Amneal Pharmaceuticals Company GmbH Truvada (Emtricitabine and Tenofovir Disoproxil Fumarate) Tablets, 100mg/150mg, 133mg/200mg, 167mg/250mg 8/22/2018  For the treatment of HIV-1 infection in adults and patients weighing at least 17kg; in combination with safer sex practices, for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk
52  209408  Cefepime for Injection USP, 100 grams Samson Medical Technologies, L.L.C. Maxipime (Cefepime) for Injection, 100 grams 8/22/2018  For treatment of infections caused by susceptible strains of microorganisms
51  208532 Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 200 mcg/50 mL and 400 mcg/100 mL (4 mcg/mL) Single-Dose Containers Baxter Healthcare Corporation Precedex (Dexmedetomidine Hydrochloride) in 0.9% Sodium Chloride Injection, 200 mcg/50 mL and 400 mcg/100 mL (4 mcg/mL) Single-Dose Containers. 8/21/2018  For sedation of non-intubated patients prior to and/or during surgical and other procedures
50 090589 Epinephrine Injection USP, 0.15 mg and 0.3 mg Teva Pharmaceuticals USA, Inc. EpiPen Jr/EpiPen (Epinephrine) Injection, 0.15 mg and 0.3 mg 8/16/2018 For the emergency treatment of allergic reactions including anaphylaxis
49 206685 Estradiol Transdermal System USP, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, 0.1 mg/day Mylan Technologies, Inc Minivelle (Estradiol) Transdermal System, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, 0.1 mg/day 8/15/2018 For the treatment of moderate to severe vasomotor symptoms due to menopause; for prevention of postmenopausal osteoporosis
48 200630 Tadalafil Tablets USP, 20 mg Mylan Pharmaceuticals Inc. Adcirca (Tadalafil) Tablets, 20 mg 8/3/2018 For the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability
47 203153 TemsiroLimus Injection, 25 mg/ml  Single Dose Vial Accord Healthcare Inc. Torisel (Temsirolimus) Injection, 25mg/ml 7/30/2018 For the treatment of advanced renal cell carcinoma
46 209549 Teriflunomide Tablets, 7 mg, 14 mg Watson Laboratories, Inc. Aubagio (Teriflunomide) Tablets, 7 mg, 14 mg 7/27/2018 For the treatment of patients with relapsing forms of multiple sclerosis
45 202586 Indium in 111 Oxyquinoline Solution, USP, 1 mCi/mL Nordion (Canada), inc. Indium in 111 Oxyquinoline Solution, 1 mCi/mL 7/25/2018 .For radiolabeling autologous leukocytes
44 207630 Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, 2% / 0.5% PF Aurobindo Pharma Limited Cosopt (Dorzolamide Hydrochloride and Timolol Maleate) Ophthalmic Solution, 2% / 0.5% PF 7/24/2018 For the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers
43 209107 Cetirizine Hydrochloride Capsules, 10 mg Aurobindo Pharma Limited Cetirizine Hydrochloride Capsules, 10 mg 7/20/2018 For temporary relief of these symptoms due to hay fever or other respiratory allergies: runny nose; itchy, watery eyes; sneezing; itching of the nose or throat
42 206107 Asenapine Sublingual Tablets, 5 mg, 10 mg Sigmapharm Laboratories, LLC Saphris (Asenapine) Sublingual Tablets, 5 mg, 10 mg 7/17/2018 For the treatment of bipolar I disorder, as an adjunctive treatment to lithium or valproate in adults
41 209448 Dextrose Injection, 10% Fresenius Kabi USA, LLC Dextrose Injection USP, 10% 7/16/2018 For the treatment of hypoglycemia
40 204393 Morphine Sulfate Injection USP, 200 mg/20 mL (10 mg/mL) Single Use Vials; 500 mg/20 mL (25 mg/mL) Single Use Vials Piramal Critical Care Limited Infumorph (Morphine Sulfate) Injection, 200 mg/20 mL (10 mg/mL) Single Use Vials; 500 mg/20 mL (25 mg/mL) Single Use Vials 7/16/2018 For the management of pain severe enough to require use of an opioid analgesic by intravenous administration and for which alternative treatments are not expected to be adequate; for the epidural or intrathecal management of pain without attendant loss of motor, sensory, or sympathetic function
39 202190 Colesevelam Hydrochloride for Oral Suspension, 1.875 g/packet, 3.75 g/packet Glenmark Pharmaceuticals Limited Welchol (Colesevelam Hydrochloride) for Oral Suspension, 1.875 g/packet, 3.75 g/packet 7/16/2018 To reduce elevated low-density lipoprotein cholesterol (LDL-C) in certain adults with primary hyperlipidemia as monotherapy and in boys and post-menarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia
38 208257 Roflumilast Tablets, 500 mcg Mylan Pharmaceuticals Daliresp (Roflumilast) Tablets, 500 mcg 7/13/2018 To reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations
37 207568 Epinephrine Injection, 1 mg/mL Luitpold Pharmaceuticals, Inc Adrenalin (Epinephrine) Injection, 1 mg/mL 7/6/2018 For emergency treatment of allergic reactions, including anaphylaxis
36 205457  Budesonide Extended-Release Tablets, 9 mg 
 
Actavis Laboratories FL, Inc.  Uceris (Budesonide) Extended Release Tablets, 9 mg 7/5/2018 For the induction of remission in patients with active, mild to moderate ulcerative colitis
35 91168 Emtricitabine capsules, 200 mg  Cipla Limited Emtriva (Emtricitabine) Capsules, 200 mg 7/2/2018 Treatment of HIV-1 infection, in combination with other antiretroviral agents
34   210723 Hydroxyprogesterone Caproate Injection USP, 250 mg/mL Single-dose Vials Luitpold Pharmaceuticals, Inc. Makena (Hydroxyprogesterone Caproate) Injection USP, 250 mg/mL Single-dose Vials  6/21/2018  To reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth
33 207607 Buprenorphine and Naloxone Sublingual Film, 8 mg/2 mg and 12 mg/3 mg Mylan Technologies Inc. Suboxone (Buprenorphine and Naloxone) Sublingual Film, 8 mg/2 mg and 12 mg/3 mg 6/14/2018 For the treatment of opioid dependence
32 205806 Buprenorphine and Naloxone Sublingual Film, 4 mg/1 mg and 12 mg/3 mg Dr. Reddy's Laboratories SA Suboxone (Buprenorphine and Naloxone) Sublingual Film, 4 mg/1 mg and 12 mg/3 mg 6/14/2018 For the treatment of opioid dependence
31 205299 Buprenorphine and Naloxone Sublingual Film, 2 mg/0.5 mg and 8 mg/2 mg Dr. Reddy's Laboratories SA Suboxone  (Buprenorphine and Naloxone) Sublingual Film, 2 mg/0.5 mg and 8 mg/2 mg 6/14/2018 For the treatment of opioid dependence
30 206166 Ropivacaine Hydrochloride Injection USP, 200 mg/100 mL (2 mg/mL), 500 mg/100 mL (5 mg/mL), 400 mg/200 mL (2 mg/mL), and 1,000 mg/200 mL (5 mg/mL) Infusion Bags  Inforlife SA  Naropin (Ropivacaine Hydrochloride) Injection USP, 200 mg/100 mL (2 mg/mL), 500 mg/100 mL (5 mg/mL), 400 mg/200 mL (2 mg/mL), and 1,000 mg/200 mL (5 mg/mL) Infusion Bags 6/11/2018 For the production of local or regional anesthesia for surgery and for acute pain management
29 207107 Esmolol Hydrochloride in Sodium Chloride Injection, 2,500 mg / 250 mL (10 mg/mL) and 2,000 mg/100 mL (20 mg/mL) Sagent Pharmaceuticals, Inc. Brevibloc (Esmolol Hydrochloride in Sodium Chloride) Injection, 2,500 mg / 250 mL (10 mg/mL) and 2,000 mg/100 mL (20 mg/mL)
 
6/8/2018 

For the short-term treatment of control of ventricular rate in supraventricular tachycardia, including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia; control of perioperative tachycardia and hypertension

 

28  206608   Esmolol Hydrochloride in Sodium Chloride Injection, 2,500 mg/250mL (10 mg/mL) Single-Dose Plastic Bag, and 2,000 mg/100 mL (20 mg/mL) Single-Dose Plastic Bag   Mylan Pharmaceuticals Brevibloc (Esmolol Hydrochloride in Sodium Chloride) Injection, 2,500 mg/250mL (10 mg/mL) Single-Dose Plastic Bag, and 2,000 mg/100 mL (20 mg/mL) Single-Dose Plastic Bag 6/8/2018

For the short-term treatment of control of ventricular rate in supraventricular tachycardia, including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia; control of perioperative tachycardia and hypertension

 

27   208683 Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/3.75% 
 
Taro Pharmaceuticals U.S.A., Inc.  Onexto (Clindamycin Phosphate and Benzoyl Peroxide) gel, 1.2%/3.75% 6/5/2018  For the topical treatment of acne vulgaris in patients 12 years of age and older
26 207329 Oxybutynin Chloride Gel, 10%  Par Pharmaceutical, Inc. Gelnique (Oxybutynin Chloride) Gel, 10% 5/31/2018 For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
25 090141 Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg  Teva Pharmaceutical USA, Inc. Cialis Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg 5/22/2018 For the treatment of erectile dysfunction (ED), signs and symptoms of benign prostatic hyperplasia (BPH), ED and the signs and symptoms of BPH (ED/BPH)
24 206049 Methylphenidate Hydrochloride for Extended-Release Oral Suspension, 300 mg/60 mL total volume, 600 mg/120 mL total volume, 750 mg/150 mL total volume, and 900 mg/180 mL total volume (5 mg/mL)  Actavis Laboratories FL, Inc. QUILLIVANT XR® (Methylphenidate Hydrochloride) for Extended-Release Oral Suspension, 25 mg per 5 mL 5/17/2018 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD)
23 091600 Colesevelam Hydrochloride Tablets, 625 mg  Impax Laboratories, Inc. Welchol (Colesevelam Hydrochloride)Tablets, 625 mg 5/16/2018 To reduce elevated low-density lipoprotein cholesterol (LDL-C) in certain adults with primary hyperlipidemia as monotherapy and in boys and post-menarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia
22 209373 Phytonadione Tablets USP, 5 mg  Amneal Pharmaceuticals Company GmbH Mephyton (Phytonadione) Tablets, 5 mg 5/11/2018 For the treatment of anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives, hypoprothrombinemia secondary to antibacterial therapy, hypoprothrombinemia secondary to administration of salicylates, certain hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas
21 209467 Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) Multiple-Dose Vials  Zydus Pharmaceuticals (USA), Inc. Quelicin (Succinylcholine Chloride) Injection USP, 200 mg/10 mL (20 mg/mL) Multiple-Dose Vials 5/4/2018 As an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation
20 210334 Phenylephrine Hydrochloride Injection USP, 10 mg/mL SingleDose Via  Cipla Limited Phenylephrine Hydrochloride 4/27/2018 For increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia
19  210333 Phenylephrine Hydrochloride Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package  Cipla Limited Vazculep (Phenylephrine Hydrochloride) Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package 4/27/2018 For the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesi
18  202159 Hydromorphone Hydrochloride Injection USP, 2 mg/mL Single-Dose Vial  Eurohealth International Sarl Dilaudid (Hydromorphone Hydrochloride) Injection USP, 2 mg/mL Single-Dose Vial 4/27/2018 For management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate
17  208342 Miglustat Capsules, 100 mg  Amerigen Pharmaceuticals Limited Zavesca (Miglustat) Capsules, 100 mg 4/17/2018 For treatment of adult patients with mild/moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option
16  210088 Loratadine Chewable Tablets USP, 5 mg (OTC)  Sun Pharma Global FZE Children’s Claritin (Loratadine) Chewable Tablets, 5 mg 4/16/2018 For seasonal allergic rhinitis and idiopathic urticaria
15  208790 Ertapenem for Injection, 1 gram (base)/ Single-dose vial  ACS DOBFAR SPA  Invanz (Ertapenem) for Injection, 1 gram (base)/ Single-dose vial 4/16/2018

For the treatment of certain moderate to severe infections caused by susceptible bacteria

 

14  206133 Everolimus Tablets, 0.25 mg, 0.5 mg, and 0.75 mg  West-Ward Pharmaceuticals International Limited Zortress (Everolimus) Tablets, 0.25 mg, 0.5 mg, and 0.75 m 4/12/2018 For organ rejection prophylaxis in renal transplant patients with low-moderate immunologic risk
13  090308 Clozapine Orally Disintegrating Tablets, 12.5 mg  Barr Laboratories Inc. Fazaclo (Clozapine) Orally Disintegrating Tablets, 12.5 mg 4/9/2018 For use as an anti-psychotic
12 204636 Ropivacaine Hydrochloride Injection USP, 0.2%, 200 mg/100 mL and 400 mg/200 mL (2 mg/mL), single-dose infusion bottles Akorn Inc. Naropin (Ropivacaine Hydrochloride Injection USP), 0.2%, 200 mg/100 mL and 400 mg/200 mL (2 mg/mL), single-dose infusion bottles  3/16/2018 For local, regional anesthesia and acute pain management
11  208915 Cinacalcet Hydrochloride Tablets, 30 mg (base), 60 mg (base), and 90 mg (base) Cipla Limited Sensipar Tablets, 30 mg (base), 60 mg (base), and 90 mg (base) 3/8/2018  For the treatment of Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis, Hypercalcemia in adult patients with Parathyroid Carcinoma (PC), and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy
10  206125  Cinacalcet Hydrochloride Tablets, 30 mg (base), 60 mg (base) and 90 mg (base) Aurobindo Pharma Limited Sensipar Tablets, 30 mg (base), 60 mg (base), and 90 mg   3/8/2018  For the treatment of Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis, Hypercalcemia in adult patients with Parathyroid Carcinoma (PC), and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy
209594 Baclofen Injection, 20,000 mcg/20 mL (1,000 mcg/mL) Single-dose Vials Mylan Laboratories Limited  Gablofen (Baclofen) Injection, 20,000 mcg/20 mL (1,000 mcg/mL) Single-dose Vials 3/6/2018  For use in the management of severe spasticity of cerebral or spinal origin in adult and pediatric patients age 4 years and above
 
208234 Desflurane USP, Liquid for Inhalation  Shanghai Hengrui Pharmaceutical Co., Ltd.  Suprane (Desflurane USP), Liquid for Inhalation    2/26/2018  Indicated for general anesthesia
207457 Sumatriptan and Naproxen Tablets, 85 mg/500 mg   Aurobindo Pharma Limited  Treximet (Sumatriptan and Naproxen) Tablets, 85 mg/500 mg    2/15/2018  Indicated for the acute treatment of migraine with or without aura in adults 
207567 Trientine Hydrochloride Capsules USP, 250 mg 
 
Watson Laboratories, Inc Syprine (Trientine Hydrochloride) Capsules USP, 250 mg  2/7/2018  Indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Syprine should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects
091612 Tenofovir Disoproxil Fumarate Tablets, 150 mg, 200 mg, 250 mg Teva Pharmaceuticals USA, Inc. Viread (Tenofovir Disoproxil Fumarate) Tablets, 150 mg, 200 mg, and 250 mg 1/26/2018 For the treatment of HIV-1 infection; for the treatment of chronic hepatitis B
090647 Tenofovir Disoproxil Fumarate Tablets, 150 mg, 200 mg, 250 mg Aurobindo Pharma Limited Viread (Tenofovir Disoproxil Fumarate) Tablets, 150 mg, 200 mg, and 250 mg  1/26/2018  Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older.  Indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older
210375 Levocetirizine Dihydrochloride Tablets USP, 5 mg Dr. Reddy’s Laboratories Limited Xyzal (Levocetirizine Dihydrochloride Tablets USP, 5 mg) Allergy 24HR 1/19/2018 For temporary relief of these symptoms due to hay fever or other respiratory allergies: runny nose; itchy, watery eyes; sneezing; itching of the nose or throat
206223 Remifentanil Hydrochloride for Injection, 1 mg/vial, 2 mg/vial, and 5 mg/vial Fresenius Kabi USA, LLC Ultiva® Injection, 1 mg/vial, 2 mg/vial, and 5 mg/vial  1/16/2018 For intravenous administration as: an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures; for continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting; as an analgesic component of monitored anesthesia care in adult patients
209688 Potassium Chloride Extended-Release Tablets USP, 10 MEQ (750 mg), 20 MEQ (1500 mg) Paddock LLC K-Tab (Potassium Chloride Extended-Release Tablets) USP, 10 MEQ (750 mg), 20 MEQ (1500 mg) 1/12/2018 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patientes with hypokalemic periodic paralysis; for the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop (digitalized patients or patients with significant cardiac arrhythmias

Note: As outlined in the Proposed Criteria for First Generic Submissions for Purposes of ANDA, certain ANDAs are deemed “first generic” for the purposes of review prioritization. In this context, a first generic application is any received ANDA: (1) That is a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities; and (2) for which there is no previously-approved ANDA for the drug product.

*This table reflects current data as of the date the listed approval was made. Post-approval status changes, including approved use or indications, approval date, approval status, etc. are not reflected here. To view the most current information on any ANDA listed, please check its Drugs@FDA listing.
+Due to space limitations, abbreviated indications are listed. For full indication information, please check Drugs@FDA.

To view all Generic Drug Approvals and Tentative Approvals, use the "Drug Approval Reports by Month" feature on Drugs@FDA and select "Original Abbreviated New Drug Approvals (ANDAs) by Month" for Generic Approvals or "Tentative Approvals by Month" for Tentative Approvals. The database is updated daily.

Back to Top