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Antibacterial and Antifungal Product Labeling: Microbiology Susceptibility Interpretive Criteria (Breakpoints) and Quality Control Parameter Updates

Table Last Updated: January 21, 2016
New or Changes are in bold.

This table lists approved Antibacterial and Antifungal products whose Microbiology subsection, Susceptibility Interpretive Criteria and Quality Control Parameter information in the labeling, has been reviewed and is current. The labels for these products are posted on the Drugs@FDA or Daily Med websites.

Active Ingredient Product Name Company Name Type of Appli-cation Application Number Date of Most Recent FDA Review of Microbiology Susceptibility Interpretive Criteria*
Amoxicillin Amoxil (amoxicillin) Chewable Tablets   Dr. Reddy's Laboratories  NDA 50-542 09/24/15
Amoxicillin Amoxil (amoxicillin)Tablets-BID  Dr. Reddy's Laboratories  NDA 50-754 09/24/15
Amoxicillin Moxatag (amoxicillin extended-release) Tablets, 775 mg Vernalis (R&D) Limited NDA 50-813 06/09/15
Amoxicillin Amoxicillin Tablets USP, 500 mg & 875 mg Teva Pharmaceuticals USA ANDA  65-056 05/02/13
Amoxicillin  Amoxil (amoxicillin) Chewable Tablets BID  Dr. Reddy's Laboratories  NDA 50-761 09/24/15
Amoxicillin  Amoxil (amoxicillin) Oral Suspension - BID  Dr. Reddy's Laboratories  NDA 50-760 09/24/15
Amoxicillin Amoxicillin for Suspension USP, 200 mg/5 mL and
400 mg/5 mL
Teva Pharmaceuticals USA ANDA 65-119 11/20/12
Amoxicillin/clavulanate potassium AUGMENTIN (amox/clavul pot) Tablets 250 & 500 mg GlaxoSmithKline NDA 50-564 09/29/11
Amoxicillin/clavulanate potassium AUGMENTIN (amox/clav pot) Oral Susp 125 & 250 mg/5mL GlaxoSmithKline NDA 50-575 09/29/11
Amoxicillin/clavulanate potassium Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 200 mg/28.5mg per 5 mL & 400 mg/57 mg per 5 mL Teva Pharmaceutical USA ANDA 65-089 7/25/13
Amoxicillin/clavulanate potassium Amoxicillin and Clavulanate Potassium Tablets, USP (chewable)
200 mg/28.5mg & 400 mg/57 mg
Teva Pharmaceutical USA ANDA 65-205 07/08/13
Amoxicillin/clavulanate potassium AUGMENTIN (amox/clav pot) Tablet '875' GlaxoSmithKline NDA 50-720 09/29/11
Amoxicillin/clavulanate potassium AUGMENTIN XR (amoxicillin/clavulate potassium) Tablets, 1000mg/62.5mg Dr. Reddy's Laboratories NDA 50-785 08/26/11
Ampicillin sodium/sulfactam sodium  Unasyn (ampicillin sodium/sulbactam sodium) for Injection Pfizer, Inc. NDA  50-608 03/06/12
Ampicillin sodium/sulfactam sodium  Unasyn (ampicillin sodium/sulbactam sodium) for Injection, 2gm/1gm, 1gm/500mg Pfizer, Inc. ANDA  62-901 04/07/14
Ampicillin Sodium Ampicillin for Injection USP, 125mg, 250mg, 500mg, 1g and 2g per vial and 10g Pharmacy Bulk Package Sandoz, Inc. ANDA 61-395 07/17/15
Ampicillin Trihydrate Ampicillin Trihydrate Capsule 500 mg DAVA Pharmaceuticals Inc. ANDA 62-882 9/25/15
Ampicillin Trihydrate Ampicillin Trihydrate Suspension 250 mg/ 5 mL DAVA Pharmaceuticals Inc. ANDA 62-982 9/25/15
Amphotericin B AmBisome (amphotericin B) liposome for Injection Astellas Pharma U.S. Inc. NDA 50-740 03/08/12
Azithromycin Zithromax (azithromycin for injection) IV Pfizer, Inc. NDA 50-733 11/16/11
Azithromycin Zithromax (azithromycin for oral suspension) Single-Dose Packet Pfizer, Inc. NDA 50-693 11/02/12
Azithromycin Zithromax (azithromycin for oral suspension)   Pfizer, Inc. NDA 50-710 11/02/12
Azithromycin Zithromax (azithromycin) 250 mg Tablet   Pfizer, Inc. NDA 50-711 11/02/12
Azithromycin Zithromax (azithromycin) 600 mg Tablet   Pfizer, Inc. NDA 50-730 11/02/12
Azithromycin Zithromax (azithromycin) 500 mg Tablet   Pfizer, Inc. NDA 50-784 11/02/12
Azithromycin  Zithromax (azithromycin) ER Tablet   Pfizer, Inc. NDA 50-797 10/11/13
Aztreonam  AZACTAM (aztreonam for injection, USP) Bristol Myers Squibb Co NDA 50-580 06/17/13
Aztreonam  AZACTAM (aztreonam injection) in GALAXY Plastic Container (PL 2040) for Intravenous Use Bristol Myers Squibb Co NDA  50-632 06/17/13
Cefaclor Cefaclor 500 mg Tablet Extended Release Teva Pharmaceutical USA ANDA 65-058 01/22/15
Cefaclor Cefaclor Capsules, USP, 250 mg and 500 mg West-Ward Pharmaceutical Corp. ANDA 65-350 07/24/15
Cefaclor Cefaclor Oral Suspension Yung Shin Pharmaceutical Industrial Co. Ltd. ANDA 65-412 10/14/15
Cefadroxil  Cefadroxil Tablets, USP, 1000 mg Teva Pharmaceuticals USA ANDA 62-774 04/18/12
Cefadroxil hemihydrate Cefadroxil Hemihydrate Oral Suspension Lupin ANDA 65-396 04/18/14
Cefazolin & Dextrose  Cefazolin for Injection, USP & Dextrose Injection in the Duplex Container, 1g Intravenous B. Braun Medical, Inc. NDA 50-779 10/08/15
Cefazolin Cefazolin for Injection, USP, Pharmacy Bulk Package bags SmartPak 100g & 300g Samson Medical Tech, LLC ANDA 65-141 07/30/13
Cefazolin Cefazolin for Injection USP, 10 g Pharmacy Bulk
Package
Hospira, Inc. ANDA 65-247 01/17/13
Cefdinir Omnicef (cefdinir) Capsules Abbott Laboratories NDA 50-739 11/18/15
Cefdinir Omnicef (cefdinir) Capsules Abbott Laboratories NDA 50-739 11/18/15
Cefditoren Pivoxil Spectracef (cefditoren pivoxil) 200mg & 400 mg Tablets Vansen Pharma NDA  21-222 08/06/12
Cefepime Hydrochloride Maxipime (cefepime hydrochloride, USP) for Injection Hospira, Inc. NDA 50-679 05/01/14
Cefepime Hydrochloride Cefepime (cefepime hydrochloride) Injection Baxter Healthcare Corp NDA 50-817 06/04/14
Cefepime Cefepime for Injection USP and Dextrose Injection USP in Duplex Container B. Braun Medical, Inc. NDA 50-821 06/06/14
Cefixime Suprax (cefixime) Oral Capsule 400 mg  Lupin Ltd. NDA 203195 01/07/16
Cefixime Suprax (cefixime) for Oral Suspension 500 mg/5 mL Lupin Ltd. NDA  202091 01/07/16
Cefixime Suprax (cefixime) Chewable Tablets, 200 mg Lupin Ltd. ANDA  65-380 03/29/13
Cefobid Cefobid (cefoperazone sodium ) IM/IV Pfizer Inc NDA 50-551 03/18/15
Cefotaxime sodium Claforan (cefotaxime sodium) Sterile IV/IM Sanofi Aventis US LLC NDA 50-547 03/03/15
Cefotaxime sodium Claforan (cefotaxime sodium) Injection Sanofi Aventis US LLC NDA 50-596 03/03/15
Cefotaxime sodium Cefotaxime Sodium Add Vantage 1 g & 2 g Vial Sanofi Aventis US LLC ANDA 62-659 03/03/15
Cefoxitin  Mefoxin (cefoxitin for injection) 1g/10mL, 2g/20mL & 10g/100mL Mylan Institutional LLC NDA 50-517 05/10/13
Cefoxitin and Dextrose Cefoxitin and Dextrose in Duplex Container B.Braun Medical, Inc. NDA 65-214 06/05/13
Cefpodoxime Proxetil Cefpodoxime Proxetil Tablets USP, 100 mg and 200 mg Sandoz Inc. ANDA 65-462 02/05/14
Cefpodoxime Proxetil Cefpodoxime Proxetil Oral Suspension,
100 mg/5 mL
Sandoz Inc. ANDA 90-031 06/02/14
Ceftaroline fosamil Teflaro (ceftaroline fosamil) for Injection Cerexa, Inc. NDA 200327 05/29/13
Ceftazidime Ceftazidime in Dextrose Container B. Braun NDA 50-823 05/15/15
Ceftazidime - avibactam AVYCAZ (ceftazidime-avibactam) for injection Cerexa, Inc. NDA 206494 02/25/15
Ceftazidime sodium Fortaz (ceftazidime) Powder for Injection Covis Injectables NDA 50-578 09/24/14
Ceftazidime sodium Fortaz (ceftazidime) in Plastic Container Covis Injectables NDA 50-634 09/24/14
Ceftibuten CEDAX (ceftibuten) Capsules Shionogi USA, Inc. NDA 50-685 11/04/10
Ceftibuten CEDAX (ceftibuten) Oral Suspension Shionogi USA, Inc. NDA 50-686 11/04/10
Ceftolozane and Tazobactam ZERBAXA (ceftolozane and tazobactam) Cubist Pharmaceuticals, Inc. NDA 206829 12/19/14
Ceftriaxone sodium Rocephin (ceftriaxone sodium) for Injection Hoffman-La Roche, Inc. NDA 50-585 06/30/15
Ceftriaxone sodium Rocephin (ceftriaxone sodium)  for Injection,
500 mg and 1 gm vials
Hoffman-La Roche, Inc. ANDA 63-239 06/25/15
Ceftriaxone sodium Ceftriaxone for Injection, USP (ceftriaxone powder for injection, 250 mg, 500 mg, 1 & 2 g) Sandoz, Inc. ANDA 65-169 09/27/13
Ceftriaxone sodium Ceftriaxone for Injection, USP (ceftriaxone powder for injection, 10 g per 100 mL Vial (PBP) Sandoz, Inc. ANDA 65-168 09/27/13
Ceftriaxone sodium Ceftriaxone for Injection, 1 g & 2 g ADD-Vantage Vials Sandoz, Inc. ANDA 65-204 09/27/13
Ceftriaxone sodium Ceftriaxone Sodium Injectable 1 mg &
500 mg base/vial
Sandoz, Inc. ANDA 63-239 06/25/15
Ceftriaxone and Dextrose Ceftriaxone for Injection and Dextrose Injection in the Duplex Container, 1g and 2g B.Braun Medical, Inc. NDA 50-796 07/09/15
Cefuroxime Axetil Ceftin (cefuroxime axetil) Tablet GlaxoSmithKline NDA 50-605 06/26/15
Cefuroxime Axetil Ceftin for Oral Suspension (cefuroxime axetil powder for oral suspension) GlaxoSmithKline NDA 50-672 06/26/15
Cefuroxime Sodium Zinacef (cefuroxime) Powder for injection Covis Injectables NDA 50-558 09/25/14
Cefuroxime Sodium Zinacef (cefuroxime) in Plastic Container Covis Injectables NDA 50-643 09/25/14
Cefuroxime Cefuroxime for Injection USP and Dextrose Injection USP B. Braun NDA 50-780 05/01/15
Cephalexin Keflex (cephalexin USP) Capsules Shionogi, Inc. NDA 50405 10/30/15
Cephalexin  Cephalexin Tablets, 500 mg Teva Pharmaceuticals ANDA 63-024 04/18/12
Ciprofloxacin HCl Cipro (ciprofloxacin HCl) Tablets Bayer Healthcare Pharmaceuticals NDA 19-537 01/30/13
Ciprofloxacin HCl Cipro I.V. (ciprofloxacin hydrochloride) 1% Solution in Vials Bayer Healthcare Pharmaceuticals NDA 19-847 01/30/13
Ciprofloxacin HCl Cipro (ciprofloxacin hydrochloride) Solution in 5% Dextrose Bayer Healthcare Pharmaceuticals NDA 19-857 01/30/13
Ciprofloxacin HCl Cipro (ciprofloxacin HCl)  5% and 10% Oral Suspension Bayer Healthcare Pharmaceuticals NDA 20-780 01/30/13
Ciprofloxacin HCl Cipro XR (ciprofloxacin HCl) Tablets Bayer Healthcare Pharmaceuticals NDA 21-473 01/30/15
Ciprofloxacin HCl Ciprofloxacin Extended Release Tablets
500 mg and 1000 mg
Mylan Pharms Inc. ANDA 78-183 8/14/13
Ciprofloxacin HCl Proquin XR (ciprofloxacin hydrochloride) Depomed, Inc. NDA 21-744 12/29/10
Clarithromycin  BIAXIN Filmtabs (clarithromycin tablets, USP) Abbott Laboratories NDA 50-662 05/03/12
Clarithromycin  BIAXIN Granules (clarithromycin for oral suspension, USP) Abbott Laboratories NDA 50-698 05/03/12
Clarithromycin  BIAXIN XL Filmtabs (clarithromycin ER tablets) Abbott Laboratories NDA 50-775 05/03/12
Clindamycin hydrochloride Cleocin HCl (clindamycin hydrochloride) 75mg, 150 mg, 300 mg capsules Pfizer, Inc.  NDA 50-162  06/07/11
Clindamycin phosphate and dextrose Cleocin Phosphate (clindamycin phosphate with 5% dextrose) injection Pfizer, Inc. NDA 50-639 06/07/11
Clindamycin phosphate Cleocin Phosphate (clindamycin phosphate, USP) Injection  Pfizer, Inc. NDA 50-441 06/07/11
Dalbavancin Hydrochloride Dalvance (dalbavancin) for Injection, for intravenous use Durata Therapeutics, Inc. NDA 21-883 05/23/14
Daptomycin  Cubicin (daptomycin for injection) Cubist Pharmaceuticals NDA 21-572 10/03/11
Demeclocycline hydrochloride Declomycin (demeclocycline hydrochloride) Tablets CorePharm LLC NDA  50-261 09/05/12
Demeclocycline hydrochloride Demeclocycline hydrochloride Tablets USP, 150 mg and 300 mg Amneal Pharm ANDA 65-425 02/05/13
Doripenem DORIBAX (doripenem for injection) Janssen Research and Development LLC NDA 22-106 01/26/12
Doxycycline DOXY 100 & 200TM (Doxycycline for Injection USP, 100 mg and 200 mg
per vial).
Fresenius Kabi USA, LLC ANDA 62-475 01/28/14
Doxycycline Doxycycline Capsules USP, 50 mg, 75 mg, 100 mg, and 150 mg Par Pharmaceuticals, Inc. ANDA 65-055 07/10/14
Doxycycline Doxycycline Tablets 50, 75, 100, & 150 mg Par Pharmaceuticals, Inc. ANDA 65-070 12/20/15
Doxycycline monohydrate Monodox (doxycycline monohydrate) Capsules Watson Laboratories, Inc. NDA 50-641 01/11/12
Doxycycline monohydrate Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension Pfizer, Inc. NDA 50-006 09/12/14
Doxycycline hyclate Vibramycin Hyclate (doxycycline hyclate capsules, USP) Capsules Pfizer, Inc. NDA  50-007 09/12/14
Doxycycline calcium  Vibramycin Calcium (doxycycline calcium oral suspension, USP) Syrup Pfizer, Inc. NDA 50-480 09/12/14
Doxycycline hyclate  Vibra-Tabs (doxycycline hyclate tablets, USP) Film Coated Tablets Pfizer, Inc. NDA  50-533 09/12/14
Doxycycline hyclate Doryx (doxycycline hyclate delayed release tablets) Tablets 80, 100, 150 & 200 mg Mayne Pharma International NDA 50-795 04/11/13
Doxycycline hyclate Doxycycline Hyclate Tablets, USP 100 mg West-Ward Pharmaceutical Corp ANDA 65-095 06/25/14
Doxycycline hyclate Doxycycline Hyclate Delayed-Release Capsules, 75 mg and 100 mg Medicis Pharmaceutical Corporation ANDA 65-281 12/21/15
Ertapenem sodium Invanz (ertapenem sodium) Merck, Sharp & Dohme NDA 21-337 02/17/12
Erythromycin  ERYC  (erythromycin delayed release capsules, USP) 250 mg Mayne Pharma International NDA  50-536 03/21/13
Erythromycin Erythromycin Tablets USP, 250 mg and 500 mg Arbor Pharmaceuticals, Inc. ANDA 61-621 12/04/13
Erythromycin ERY-TAB (erythromycin delayed-release tablets, USP) Enteric-Coated, 250
mg, 333 mg, and 500 mg.
Arbor Pharmaceuticals, Inc ANDA 62-298 12/04/13
Erythromycin ethylsuccinate  E.E.S. Granules (erythromycin ethylsuccinate for oral suspension) EryPed 200, 400, & drops Abbott Laboratories NDA 50-207 11/04/10
Erythromycin ethylsuccinate Ery-Ped Chewable Tablets (erythromycin ethylsuccinate, USP) Abbott Laboratories NDA 50-297 11/04/10
Erythromycin ethylsuccinate EES (erythromycin ethylsuccinate oral suspension, USP)
Liquid 200 mg/5 mL and 400 mg/5 mL
Arbor Pharmaceuticals, Inc. ANDA 61-639 10/31/13
Erythromycin ethylsuccinate Erythromycin Ethylsuccinate Tablets USP, 400 mg. Arbor Pharmaceuticals, Inc. ANDA 61-904 12/04/13
Erythromycin ethylsuccinate EES 400 Film-coated Tablets (erythromycin ethylsuccinate tablets, USP) 400 mg Arbor Pharmaceuticals, Inc ANDA 61-905 10/31/13
Erythromycin Ethylsuccinate and Sulfisoxazole Acetyl Erythromycin ethylsuccinate and sulfisoxazole acetyl granule, for suspension, oral 200 mg base/5 mL Barr Laboratories Inc. ANDA 62-759 12/16/15
Erythromycin lactobionate Erythrocin Lactobionate-I.V. (erythromycin lactobionate for injection, USP)  vials Hospira, Inc. NDA 50-609 06/09/11
Erythromycin lactobionate Erythromycin Lactobionate I.V. (erythromycin lactobioinate for injection, USP) 500 mg and 1 g ADD-Vantage Vials Hospira, Inc. ANDA 62-638 08/26/13
Erythromycin particles  PCE Tablets (erythromycin particles in tablets) Dispertab Tablets Abbott Laboratories NDA 50-611 11/04/10
Erythromycin stearate Erythrocin Stearate (erythromycin stearate tablets, USP) Film-coated Tablets, 250 mg Arbor Pharmaceuticals, Inc. ANDA 60-359 12/04/13
Fosfomycin tromethamine Monurol (fosfomycin tromethamine) Sachet Forest Laboratories, Inc. NDA 50-717 03/15/10
Gemifloxacin mesylate Factive (gemifloxacin mesylate) Tablet Cornerstone Therapeutics, Inc. NDA 21-158 10/18/11
Gentamicin Sulfate Gentamicin Sulfate in 0.9% Sodium Chloride Injection in Plastic Container Baxter Healthcare Corporation ANDA 62-373 12/11/15
Gentamicin Sulfate Gentamicin Sulfate Injection Fresenius Kabi USA LLC ANDA 62-366 03/07/14
Imipenem and Cilastatin Primaxin I.V. (imipenem and cilastatin for injection) Merck, Sharp & Dohme NDA 50-587 04/16/12
Kanamycin Injection Kanamycin Injection USP,
1 gm per 3 mL
Fresenius Kabi, USA, LLC ANDA 65-111 07/15/15
Levofloxacin Levaquin (levofloxacin) Tablet Johnson & Johnson NDA 20-634 06/10/11
Levofloxacin Levaquin (levofloxacin) Injection Johnson & Johnson NDA 20-635 06/09/11
Levofloxacin Levaquin (levofloxacin) Oral Solution Johnson & Johnson NDA 21-721 06/09/11
Lincomycin hydrochloride Lincocin (lincomycin hydrochloride Injection, USP) Sterile Solution Pfizer Inc. NDA 50-317 10/15/14
Linezolid Zyvox (linezolid) Tablets Pfizer Inc. NDA 21-130 06/05/15
Linezolid Zyvox (linezolid) IV Injection Pfizer Inc. NDA 21-131 06/05/15
Linezolid Zyvox (linezolid) Oral Suspension Pfizer Inc. NDA 21-132 06/05/15
Meropenem  MERREM IV (meropenem for injection) AstraZeneca UK Limited NDA 50-706 03/28/13
Methenamine hippurate  Hiprex (methenamine hippurate tablets, USP) Sanofi Aventis NDA 17-681 03/15/10
Metronidazole   Metronidazole Injection, USP RTU in Plastic Container Baxter Healthcare Corporation NDA 18-657 07/13/15
Metronidazole   Metronidazole Injection USP (5 mg/mL) in PAB Plastic Container B. Braun NDA 18-900 07/13/15
Metronidazole   Metronidazole Injection USP, 500 mg (5 mg/mL) in Flexible Containers Hospira NDA 18-890 07/13/15
Metronidazole   Flagyl (metronidazole) Tablets GD Searle LLC NDA 12-623 07/13/15
Metronidazole 
hydrochloride 
Flagyl (metronidazole hydrochloride) Intravenous GD Searle LLC NDA 18-353 07/13/15
Metronidazole   Flagyl (metronidazole) Capsules GD Searle LLC NDA 20-334 07/13/15
Metronidazole   Flagyl (metronidazole) Extended Release Tablets GD Searle LLC NDA 20-868 07/13/15
Micafungin sodium Mycamine (micafungin sodium) For Injection; IV Infusion Only Astellas Pharma U.S. Inc. NDA 21-506 04/19/13
Minocycline  Minocycline Capsules Teva Pharmaceuticals  ANDA 63-009 01/02/13
Minocycline Hydrochloride Dynacin (minocycline hydrochloride tablets, USP) 50 mg, 75 mg and 100 mg Par Pharmaceuticals Inc. ANDA 65-131 05/11/12
Moxifloxacin hydrochloride Avelox (moxifloxacin hydrochloride) Tablets Bayer HealthCare Pharmaceuticals, Inc. NDA 21-085 10/18/11
Moxifloxacin hydrochloride Avelox (moxifloxacin hydrochloride) IV Bayer HealthCare Pharmaceuticals, Inc. NDA 21-277 10/18/11
Nafcillin Nafcillin Injection, USP in Plastic Galaxy Container, PL 2040 Baxter Healthcare Corporation NDA 50-655 11/09/11
Nalidixic acid Negram (nalidixic acid) Sanofi Aventis NDA 14-214 11/28/12
Neomycin Sulfate  Neomycin Sulfate Tablet, USP, 500 mg Teva Pharmaceuticals ANDA 60-304 11/30/11
Neomycin Sulfate  Neo-fradin (neomycin sulfate Oral Solution, USP) 125 mg/5 mL X Gen Pharmaceuticals, Inc. ANDA 65-010 01/17/12
Nitrofurantoin  Furadantin (nitrofurantoin) Oral Suspension Shionogi, Inc. NDA 9-175 11/04/13
Nitrofurantoin, Macrocrystalline Macrodantin Capsules Almatica Pharma NDA 16-620 06/06/11
Nitrofurantoin; Nitrofurantoin, Macrocrystalline Macrobid Capsules P & G Pharmaceuticals NDA 20-064 06/06/11
Norfloxacin Noroxin (norfloxacin) Tablets Merck, Sharp & Dohme NDA 19-384 05/27/11
Ofloxacin Ofloxacin Tablets
200 mg, 300 mg &
400 mg
Teva Pharmaceuticals USA ANDA 76-182 04/10/14
Oritavancin diphosphate Orbactiv (oritavancin diphosphate) Lyophilized Powder for Injection, 400 mg/vial The Medicines Company NDA 206334 08/06/14
Oxacillin Oxacillin Injection, USP in Plastic Galaxy Container, PL 2040 Baxter Healthcare Corporation NDA 50-640 01/06/15
Penicillin G benzathine & penicillin G Procaine  Bicillin C-R Disposable Syringe for Deep IM Injection Only & Bicillin C-R 900/300 2 mL Syringe King Pharmaceuticals, Inc. NDA 50-141 10/13/15
Penicillin G benzathine  Bicillin L-A (pen G Benzathine Inj Solution) Disposable Syringe King Pharmaceuticals, Inc. NDA  50-138 10/13/15
Penicillin G Penicillin G Injection, USP in Galaxy Plastic Container  Baxter Healthcare Corporation NDA 50-638 04/16/12
Penicillin G Penicillin G Procaine Injection, Suspension
1 mL and 2 mL Syringe
King Pharmaceuticals, Inc. ANDA 60-101 12/16/15
Penicillin G Sodium Penicillin G Sodium Sandoz ANDA 65-068 10/11/12
Penicillin V Potassium Penicillin V Potassium Sandoz ANDA 64-071 10/11/12
Penicillin V Potassium Penicillin V Potassium Tablets USP, 250 mg & 500 mg and Penicillin V Potassium for Oral Solution, USP, 125 mg/
5 mL and 250 mg/5 mL
Teva Pharmaceuticals USA, Inc. ANDA 60-456 07/16/14
Piperacillin Sodium /tazobactam  Zosyn (piperacillin and tazobactam) for Injection, 2.25g, 3.375g and 4.5g Vials & 40.5 Bulk Pharmacy Vials Pfizer Inc. NDA 50-684 09/06/13
Piperacillin sodium/tazobactam sodium Zosyn (piperacillin sodium/tazobactam sodium) in Galaxy Containers Pfizer Inc. NDA 50-750 09/06/13
Polymyxin B Sulfate Polymyxin B Sulfate Injection Bedford Laboratories ANDA 60-716 01/27/12
Quinupristin and dalfopristin Synercid (quinupristin and dalfopristin for injection) King Pharmaceuticals, Inc. NDA 50-748 01/13/12
Spectinomycin hydrochloride Trobicin (spectinomycin hydrochloride) Sterile Powder  Pfizer, Inc.  NDA 50-347 11/15/11
Streptomycin  Streptomycin for Injection, USP, 1 gram X Gen Pharmaceuticals, Inc. ANDA 64-210 04/30/12
Sulfamethoxazole; Trimethoprim Bactrim Tablets, USP and Bactrim DS (double strength) Tablets URL Mutual Pharmaceutical  NDA 17-377 06/28/10
Sulfamethoxazole; Trimethoprim Sulfamethoxazole & Trimethoprim Injection 80 & 16 mg/mL Teva Pharmaceuticals USA ANDA 73-303 04/29/13
Sulfamethoxazole and Trimethoprim Sulfamethoxazole & Trimethoprim Oral Suspension, USP, 200 mg/40 mg per 5mL Hi Tech Pharmacal Co ANDA 74-650 12/15/11
Tedizolid Phosphate Sivextro (tedizolid phosphate) Tablet Cubist Pharmaceuticals, Inc. NDA 205435 06/20/14
Tedizolid Phosphate Sivextro (tedizolid phosphate) Injection Cubist Pharmaceuticals, Inc. NDA 205436 06/20/14
Telavancin Vibativ (telavancin) for Injection 250 & 750 mg Theravance, Inc. NDA 22-110 02/07/14
Telithromycin Ketek (telithromycin) Tablet Sanofi Aventis NDA 21-144 03/09/15

Tetracycline Hydrochloride

Tetracycline Hydrochloride Capsules USP, 250 mg and 500 mg

IVAX Pharmaceuticals, Inc.

ANDA

60-704

01/27/14

Ticarcillin disodium & clavulanate potassium 

Timentin (Sterile ticarcillin disodium & clavulanate potassium) for IV Administration

GlaxoSmithKline

NDA

50-590

06/09/11

Ticarcillin disodium & Clavulante potassium (sterile)

Timentin Galaxy Plastic Container (sterile ticarcillin disodium & Clavulante potassium)

GlaxoSmithKline

NDA

50-658

06/09/11

Tigecycline

Tygacil (tigecycline)

Wyeth Pharmaceuticals

NDA

21-821

03/15/10

Tobramycin 

Tobramycin Injection USP, Pharmacy Bulk Package -1.2 gram

X Gen Pharmaceuticals, Inc.

ANDA

65-013

01/17/12

Tobramycin

TOBI (tobramycin inhalation solution, USP)

Novartis Pharmaceuticals Corp.

NDA

50-753

03/15/10

Tobramycin

Tobramycin Injection USP, 10 mg/ml

Hospira, Inc.

ANDA

63-112

01/12/12

Tobramycin

Tobramycin Injection USP, 40 mg/mL in 2 mL

Fresenius Kabi USA, LLC

ANDA

65-122

01/29/14

Tobramycin Sulfate 

Tobramycin in 0.9% Sodium Chloride Injection

Hospira, Inc.

ANDA

63-081

12/08/11

Tobramycin Sulfate

Tobramycin Injection USP, Pharmacy Bulk Package -2-grams

Hospira, Inc.

ANDA

63-116

12/08/11

Vancomycin hydrochloride 

Vancocin (vancomycin hydrochloride, USP) Capsules

ViroPharma, Inc.

NDA

50-606

12/14/11

Vancomycin hydrochloride 

Vancomycin Hydrochloride for injection, USP, 500 mg vial

Hospira, Inc.

ANDA

62-911

11/30/11

Vancomycin hydrochloride

Vancomycin Hydrochloride for injection, USP, 1 gram vial

Hospira, Inc.

ANDA

62-912

11/30/11

Vancomycin hydrochloride 

Vancomycin Hydrochloride for injection, USP, 500 mg ADD-Vantage vial

Hospira, Inc.

ANDA

62-931

11/30/11

Vancomycin hydrochloride 

Vancomycin Hydrochloride for injection, USP, 1 gram ADD-Vantage vial

Hospira, Inc.

ANDA

62-933

11/30/11

Vancomycin Hydrochloride

Vancomycin Hydrochloride for Injection USP, Pharmacy
Bulk Package bottle - 5 grams

Hospira, Inc.

ANDA

63-076

05/22/12

Vancomycin 

VANCOCIN HCl (vancomycin injection, USP) in Galaxy Plastic Container 

Baxter Healthcare Corporation

NDA

50-671

01/17/12

Latest Update: 01/21/2016

 

Page Last Updated: 06/22/2016
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