Drugs

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 NumberGeneric NameANDA ApplicantBrand NameANDA Approval DateANDA Indication+
61210574Cefixime Capsules, 400 mgAlkem Laboratories LimitedSuprax (Cefixime) Capsules, 400 mg10/9/2018For 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)
60207141Noxivent (Nitric Oxide) Gas for Inhalation, 100 ppm and 800 ppm)Praxair Distribution, Inc. INOmax (Nitric Oxide) Gas for Inhalation, 100 ppm and 800 ppm10/2/2018For improved oxygenation and to reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure
59210434Albendazole Tablets USP, 200 mgCipla LimitedAlbenza (Albendazole) Tablets, 200 mg9/21/2018For treatment of parenchymal neurocysticercosis due to active lesion caused by larval forms of the pork tapeworm, Taenia solium
58210179Carmustine for Injection USP, 100 mg/vialNavinta LLC.BiCNU (Carmustine) for Injection, 100 mg/vial9/11/2018 For palliative therapy in certain brain tumors, multiple myeloma, relapsed or refractory Hodgkin's and Non-Hodgkin's lymphoma
57 208390Ticagrelor 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 203041Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate Tablets, 600 mg/200 mg/300 mgAurobindo Pharma LimitedAtripla (Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate) Tablets, 600 mg/200 mg/300 mg9/4/2018For the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg
55 208231Arsenic Trioxide Injection, 10 mg/10 mL (1 mg/mL) Single-dose vialFresenius Kabi USA, LLC Trisenox (Arsenic Trioxide) Injection, 10 mg/10 mL (1 mg/mL) Single-dose vial8/312018 For induction of remission and consolidation in certain patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy
54 090165Aripiprazole Orally Disintegrating Tablets USP, 20 mg, 30 mgZydus Pharmaceuticals (USA), Inc. Abilify (Aripiprazole) DISCMELT Orally Disintegrating Tablets, 20 mg, 30 mg8/28/2018 For the treatment of Schizophrenia
53 209721Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 100mg/150mg, 133mg/200mg, 167mg/250mgAmneal Pharmaceuticals Company GmbHTruvada (Emtricitabine and Tenofovir Disoproxil Fumarate) Tablets, 100mg/150mg, 133mg/200mg, 167mg/250mg8/22/2018 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 gramsSamson Medical Technologies, L.L.C.Maxipime (Cefepime) for Injection, 100 grams8/22/2018 For treatment of infections caused by susceptible strains of microorganisms
51 208532Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 200 mcg/50 mL and 400 mcg/100 mL (4 mcg/mL) Single-Dose ContainersBaxter Healthcare CorporationPrecedex (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
50090589Epinephrine Injection USP, 0.15 mg and 0.3 mgTeva Pharmaceuticals USA, Inc.EpiPen Jr/EpiPen (Epinephrine) Injection, 0.15 mg and 0.3 mg8/16/2018For the emergency treatment of allergic reactions including anaphylaxis
49206685Estradiol Transdermal System USP, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, 0.1 mg/dayMylan Technologies, IncMinivelle (Estradiol) Transdermal System, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, 0.1 mg/day8/15/2018For the treatment of moderate to severe vasomotor symptoms due to menopause; for prevention of postmenopausal osteoporosis
48200630Tadalafil Tablets USP, 20 mgMylan Pharmaceuticals Inc.Adcirca (Tadalafil) Tablets, 20 mg8/3/2018For the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability
47203153TemsiroLimus Injection, 25 mg/ml  Single Dose VialAccord Healthcare Inc.Torisel (Temsirolimus) Injection, 25mg/ml7/30/2018For the treatment of advanced renal cell carcinoma
46209549Teriflunomide Tablets, 7 mg, 14 mgWatson Laboratories, Inc.Aubagio (Teriflunomide) Tablets, 7 mg, 14 mg7/27/2018For the treatment of patients with relapsing forms of multiple sclerosis
45202586Indium in 111 Oxyquinoline Solution, USP, 1 mCi/mLNordion (Canada), inc.Indium in 111 Oxyquinoline Solution, 1 mCi/mL7/25/2018.For radiolabeling autologous leukocytes
44207630Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, 2% / 0.5% PFAurobindo Pharma LimitedCosopt (Dorzolamide Hydrochloride and Timolol Maleate) Ophthalmic Solution, 2% / 0.5% PF7/24/2018For the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers
43209107Cetirizine Hydrochloride Capsules, 10 mgAurobindo Pharma LimitedCetirizine Hydrochloride Capsules, 10 mg7/20/2018For 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
42206107Asenapine Sublingual Tablets, 5 mg, 10 mgSigmapharm Laboratories, LLCSaphris (Asenapine) Sublingual Tablets, 5 mg, 10 mg7/17/2018For the treatment of bipolar I disorder, as an adjunctive treatment to lithium or valproate in adults
41209448Dextrose Injection, 10%Fresenius Kabi USA, LLCDextrose Injection USP, 10%7/16/2018For the treatment of hypoglycemia
40204393Morphine Sulfate Injection USP, 200 mg/20 mL (10 mg/mL) Single Use Vials; 500 mg/20 mL (25 mg/mL) Single Use VialsPiramal Critical Care LimitedInfumorph (Morphine Sulfate) Injection, 200 mg/20 mL (10 mg/mL) Single Use Vials; 500 mg/20 mL (25 mg/mL) Single Use Vials7/16/2018For 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
39202190Colesevelam Hydrochloride for Oral Suspension, 1.875 g/packet, 3.75 g/packetGlenmark Pharmaceuticals LimitedWelchol (Colesevelam Hydrochloride) for Oral Suspension, 1.875 g/packet, 3.75 g/packet7/16/2018To 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
3820257Roflumilast Tablets, 500 mcgMylan PharmaceuticalsDaliresp (Roflumilast) Tablets, 500 mcg7/13/2018To reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations
37207568Epinephrine Injection, 1 mg/mLLuitpold Pharmaceuticals, IncAdrenalin (Epinephrine) Injection, 1 mg/mL7/6/2018For emergency treatment of allergic reactions, including anaphylaxis
36205457 Budesonide Extended-Release Tablets, 9 mg 
 
Actavis Laboratories FL, Inc. Uceris (Budesonide) Extended Release Tablets, 9 mg7/5/2018For the induction of remission in patients with active, mild to moderate ulcerative colitis
3591168Emtricitabine capsules, 200 mg Cipla LimitedEmtriva (Emtricitabine) Capsules, 200 mg7/2/2018Treatment of HIV-1 infection, in combination with other antiretroviral agents
34  210723Hydroxyprogesterone Caproate Injection USP, 250 mg/mL Single-dose VialsLuitpold 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
33207607Buprenorphine and Naloxone Sublingual Film, 8 mg/2 mg and 12 mg/3 mgMylan Technologies Inc.Suboxone (Buprenorphine and Naloxone) Sublingual Film, 8 mg/2 mg and 12 mg/3 mg6/14/2018For the treatment of opioid dependence
32205806Buprenorphine and Naloxone Sublingual Film, 4 mg/1 mg and 12 mg/3 mgDr. Reddy's Laboratories SASuboxone (Buprenorphine and Naloxone) Sublingual Film, 4 mg/1 mg and 12 mg/3 mg6/14/2018For the treatment of opioid dependence
31205299Buprenorphine and Naloxone Sublingual Film, 2 mg/0.5 mg and 8 mg/2 mgDr. Reddy's Laboratories SASuboxone  (Buprenorphine and Naloxone) Sublingual Film, 2 mg/0.5 mg and 8 mg/2 mg6/14/2018For the treatment of opioid dependence
30206166Ropivacaine 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 Bags6/11/2018For the production of local or regional anesthesia for surgery and for acute pain management
29207107Esmolol 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 PharmaceuticalsBrevibloc (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 Bag6/8/2018

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  208683Clindamycin 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
26207329Oxybutynin Chloride Gel, 10% Par Pharmaceutical, Inc.Gelnique (Oxybutynin Chloride) Gel, 10%5/31/2018For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
25090141Tadalafil 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 mg5/22/2018For the treatment of erectile dysfunction (ED), signs and symptoms of benign prostatic hyperplasia (BPH), ED and the signs and symptoms of BPH (ED/BPH)
24206049Methylphenidate 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 mL5/17/2018For the treatment of Attention Deficit Hyperactivity Disorder (ADHD)
23091600Colesevelam Hydrochloride Tablets, 625 mg Impax Laboratories, Inc.Welchol (Colesevelam Hydrochloride)Tablets, 625 mg5/16/2018To 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
22209373Phytonadione Tablets USP, 5 mg Amneal Pharmaceuticals Company GmbHMephyton (Phytonadione) Tablets, 5 mg5/11/2018For 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
21209467Succinylcholine 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 Vials5/4/2018As an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation
20210334Phenylephrine Hydrochloride Injection USP, 10 mg/mL SingleDose Via Cipla LimitedPhenylephrine Hydrochloride4/27/2018For increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia
19 210333Phenylephrine Hydrochloride Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package Cipla LimitedVazculep (Phenylephrine Hydrochloride) Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package4/27/2018For the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesi
18 202159Hydromorphone Hydrochloride Injection USP, 2 mg/mL Single-Dose Vial Eurohealth International SarlDilaudid (Hydromorphone Hydrochloride) Injection USP, 2 mg/mL Single-Dose Vial4/27/2018For management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate
17 208342Miglustat Capsules, 100 mg Amerigen Pharmaceuticals LimitedZavesca (Miglustat) Capsules, 100 mg4/17/2018For treatment of adult patients with mild/moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option
16 210088Loratadine Chewable Tablets USP, 5 mg (OTC) Sun Pharma Global FZEChildren’s Claritin (Loratadine) Chewable Tablets, 5 mg4/16/2018For seasonal allergic rhinitis and idiopathic urticaria
15 208790Ertapenem for Injection, 1 gram (base)/ Single-dose vial ACS DOBFAR SPA Invanz (Ertapenem) for Injection, 1 gram (base)/ Single-dose vial4/16/2018

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

 

14 206133Everolimus Tablets, 0.25 mg, 0.5 mg, and 0.75 mg West-Ward Pharmaceuticals International LimitedZortress (Everolimus) Tablets, 0.25 mg, 0.5 mg, and 0.75 m4/12/2018For organ rejection prophylaxis in renal transplant patients with low-moderate immunologic risk
13 090308Clozapine Orally Disintegrating Tablets, 12.5 mg Barr Laboratories Inc.Fazaclo (Clozapine) Orally Disintegrating Tablets, 12.5 mg4/9/2018For use as an anti-psychotic
12204636Ropivacaine Hydrochloride Injection USP, 0.2%, 200 mg/100 mL and 400 mg/200 mL (2 mg/mL), single-dose infusion bottlesAkorn Inc.Naropin (Ropivacaine Hydrochloride Injection USP), 0.2%, 200 mg/100 mL and 400 mg/200 mL (2 mg/mL), single-dose infusion bottles 3/16/2018For local, regional anesthesia and acute pain management
11 208915Cinacalcet Hydrochloride Tablets, 30 mg (base), 60 mg (base), and 90 mg (base)Cipla LimitedSensipar 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 LimitedSensipar 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
209594Baclofen Injection, 20,000 mcg/20 mL (1,000 mcg/mL) Single-dose VialsMylan Laboratories Limited Gablofen (Baclofen) Injection, 20,000 mcg/20 mL (1,000 mcg/mL) Single-dose Vials3/6/2018 For use in the management of severe spasticity of cerebral or spinal origin in adult and pediatric patients age 4 years and above
 
208234Desflurane USP, Liquid for Inhalation Shanghai Hengrui Pharmaceutical Co., Ltd. Suprane (Desflurane USP), Liquid for Inhalation   2/26/2018 Indicated for general anesthesia
207457Sumatriptan 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 
207567Trientine Hydrochloride Capsules USP, 250 mg 
 
Watson Laboratories, IncSyprine (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
091612Tenofovir Disoproxil Fumarate Tablets, 150 mg, 200 mg, 250 mgTeva Pharmaceuticals USA, Inc.Viread (Tenofovir Disoproxil Fumarate) Tablets, 150 mg, 200 mg, and 250 mg1/26/2018For the treatment of HIV-1 infection; for the treatment of chronic hepatitis B
090647Tenofovir Disoproxil Fumarate Tablets, 150 mg, 200 mg, 250 mgAurobindo Pharma LimitedViread (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
210375Levocetirizine Dihydrochloride Tablets USP, 5 mgDr. Reddy’s Laboratories LimitedXyzal (Levocetirizine Dihydrochloride Tablets USP, 5 mg) Allergy 24HR1/19/2018For 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
206223Remifentanil Hydrochloride for Injection, 1 mg/vial, 2 mg/vial, and 5 mg/vialFresenius Kabi USA, LLCUltiva® Injection, 1 mg/vial, 2 mg/vial, and 5 mg/vial 1/16/2018For 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
209688Potassium Chloride Extended-Release Tablets USP, 10 MEQ (750 mg), 20 MEQ (1500 mg)Paddock LLCK-Tab (Potassium Chloride Extended-Release Tablets) USP, 10 MEQ (750 mg), 20 MEQ (1500 mg)1/12/2018For 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.

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