| Product |
Company |
Generic name |
KEGG DRUG |
|
OXYGEN gas 99 L00L (NDA)
|
Lampton Welding Supply Company, Inc |
OXYGEN |
D00003
|
|
Jevtana kit (NDA)
|
Sanofi-Aventis U.S. LLC |
cabazitaxel |
D10452
|
Benazepril Hydrochloride and Hydrochlorothiazide tablet 5 mg (ANDA)
Benazepril Hydrochloride and Hydrochlorothiazide tablet 10 mg (ANDA)
Benazepril Hydrochloride and Hydrochlorothiazide tablet 20 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Benazepril Hydrochloride and Hydrochlorothiazide |
D10279
|
Apidra injection, solution 100 [iU]/mL (BLA)
Apidra SoloStar injection, solution 100 [iU]/mL (BLA)
|
sanofi-aventis U.S. LLC |
insulin glulisine |
D04540
|
|
Lidocaine Hydrochloride injection, solution 10 mg/mL (ANDA)
|
Spectra Medical Devices, LLC |
LIDOCAINE HYDROCHLORIDE ANHYDROUS |
D02086
|
|
MERILOG injection, solution 100 [iU]/mL (BLA)
|
Sanofi-Aventis U.S. LLC |
insulin aspart-szjj |
D04475
|
|
Zolpidem Tartrate tablet, film coated 10 mg (ANDA)
|
A-S Medication Solutions |
Zolpidem Tartrate |
D00706
|
|
DILTIAZEM HYDROCHLORIDE injection, solution 5 mg/mL (ANDA)
|
Eugia US LLC |
diltiazem hydrochloride |
D00616
|
|
Gadoterate Meglumine injection 376.9 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
gadoterate meglumine |
D03355
|
|
Simvastatin tablet, film coated 80 mg (ANDA)
|
A-S Medication Solutions |
Simvastatin |
D00434
|
|
Nitrogen gas 990 mL/L (NDA)
|
Mississippi Welders Supply Company, Inc. |
Nitrogen |
D00083
|
|
carmustine kit (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
carmustine |
D00254
|
Fenofibrate tablet, film coated 48 mg (ANDA)
Fenofibrate tablet, film coated 145 mg (ANDA)
|
Mylan Pharmaceuticals Inc. |
fenofibrate |
D00565
|
|
SOTALOL HYDROCHLORIDE tablet 120 mg (ANDA)
|
Bryant Ranch Prepack |
SOTALOL HYDROCHLORIDE |
D01026
|
|
Zetia tablet 10 mg (NDA)
|
Organon LLC |
Ezetimibe |
D01966
|
|
Oxygen Carbon Dioxide gas 950 mL/L (NDA)
|
MEDICAL-TECHNICAL GASES, INC. |
Oxygen Carbon Dioxide |
|
|
Air gas 1000 mL/L (NDA)
|
MEDICAL-TECHNICAL GASES, INC. |
Air |
D03043
|
VOXZOGO 0.4mg kit (NDA)
VOXZOGO 0.56mg kit (NDA)
VOXZOGO 1.2mg kit (NDA)
|
BioMarin Pharmaceutical Inc. |
vosoritide |
D11190
|
|
Oxygen gas 990 mL/L (NDA)
|
Oxarc, LLC |
Oxygen |
D00003
|
|
Amoxicillin powder, for suspension 400 mg/5mL (ANDA)
|
REMEDYREPACK INC. |
Amoxicillin |
D00229
|
|
Ixiaro injection, suspension 6 ug/.5mL (BLA)
|
Vetter Pharma Fertigung GmbH & Co. KG |
Japanese Encephalitis Vaccine, Inactivated, Adsorbed |
D05313
|
ASENAPINE tablet 5 mg (ANDA)
ASENAPINE tablet 10 mg (ANDA)
|
Sigmapharm Laboratories, LLC |
ASENAPINE |
D02995
|
|
Dichlorphenamide tablet 50 mg (ANDA)
|
Rising Pharma Holdings, Inc. |
Dichlorphenamide |
D00518
|
|
Desferal injection, powder, for solution 500 mg/5mL (NDA)
|
MITEM PHARMA |
deferoxamine mesylate |
D01186
|
|
Nitrous Oxide gas 990 mL/L (NDA)
|
DJB Gas Services, Inc |
Nitrous Oxide |
D00102
|
leflunomide tablet 10 mg (ANDA)
leflunomide tablet 20 mg (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
leflunomide |
D00749
|
|
Ticagrelor tablet 90 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Ticagrelor |
D09017
|
|
Oxygen gas 990 mL/L (NDA)
|
Dale Oxygen And Acetylene Service, Inc |
Oxygen |
D00003
|
|
Doxazosin mesylate tablet 4 mg (NDA AUTHORIZED GENERIC)
|
Aphena Pharma Solutions - Tennessee, LLC |
doxazosin mesylate |
D00608
|
|
Lacosamide Oral Solution solution 10 mg/mL (ANDA)
|
Kesin Pharma Corporation |
Lacosamide |
D07299
|
|
Gabapentin solution 250 mg/5mL (ANDA)
|
Kesin Pharma Corporation |
Gabapentin |
D00332
|
|
SOTALOL HYDROCHLORIDE tablet 80 mg (ANDA)
|
Bryant Ranch Prepack |
SOTALOL HYDROCHLORIDE |
D01026
|
|
Esomeprazole Sodium injection, powder, lyophilized, for solution 40 mg (ANDA)
|
Eugia US LLC |
Esomeprazole Sodium |
D04056
|
|
Air gas 210 mL/L (NDA)
|
Dale Oxygen And Acetylene Service, Inc |
Air |
D03043
|
|
DOJOLVI liquid .96 g/mL (NDA)
|
Ultragenyx Pharmaceutical Inc. |
Triheptanoin |
D11465
|
Fluphenazine Hydrochloride tablet, film coated 1 mg (ANDA)
Fluphenazine Hydrochloride tablet, film coated 2.5 mg (ANDA)
Fluphenazine Hydrochloride tablet, film coated 5 mg (ANDA)
Fluphenazine Hydrochloride tablet, film coated 10 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Fluphenazine Hydrochloride |
D00791
|
Lisinopril and Hydrochlorothiazide tablet 12.5 mg (ANDA)
Lisinopril and Hydrochlorothiazide tablet 25 mg (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Lisinopril and Hydrochlorothiazide |
D10268
|
|
Nitrous Oxide gas 990 mL/L (NDA)
|
Oxarc, LLC |
Nitrous Oxide |
D00102
|
|
SOTALOL HYDROCHLORIDE tablet 240 mg (ANDA)
|
Bryant Ranch Prepack |
SOTALOL HYDROCHLORIDE |
D01026
|
|
Air gas 1000 mL/L (NDA)
|
Oxarc, LLC |
Air |
D03043
|