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
MetronidazoleMetronidazole Injection USP (5 mg/mL) in PAB Plastic ContainerB. Braun Medical, Inc.NDA18-90007/13/15
MetronidazoleMetronidazole Injection USP, 500 mg (5 mg/mL) in Flexible ContainersHospira, Inc.NDA18-89007/13/15
MetronidazoleFlagyl (metronidazole) Tablets GD Searle LLCNDA12-62307/13/15
Metronidazole
hydrochlorideFlagyl (metronidazole hydrochloride) IntravenousGD Searle LLCNDA18-35307/13/15
MetronidazoleFlagyl (metronidazole) CapsulesGD Searle LLCNDA20-33407/13/15
MetronidazoleFlagly (metronidazole) Extended Release TabletsGD Searle LLCNDA20-86807/13/15
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
09/06/12
Penicillin G benzathine
Bicillin L-A Disposable Syringe
King Pharmaceuticals, Inc.
NDA
50-138
09/06/12
Penicillin G
Penicillin G Injection, USP in Galaxy Plastic Container
Baxter Healthcare Corporation
NDA
50-638
04/16/12
Penicillin G Sod |
