| Product |
Company |
Generic name |
KEGG DRUG |
|
DAPTOMYCIN injection, powder, lyophilized, for solution 500 mg0mL (ANDA)
|
Meitheal Pharmaceuticals Inc. |
DAPTOMYCIN |
D01080
|
Zenpep capsule, delayed release 3000 [USP'U] (BLA)
Zenpep capsule, delayed release 10000 [USP'U] (BLA)
Zenpep capsule, delayed release 15000 [USP'U] (BLA)
Zenpep capsule, delayed release 20000 [USP'U] (BLA)
Zenpep capsule, delayed release 40000 [USP'U] (BLA)
Zenpep capsule, delayed release 5000 [USP'U] (BLA)
Zenpep capsule, delayed release 25000 [USP'U] (BLA)
Zenpep capsule, delayed release 60000 [USP'U] (BLA)
|
Aimmune Therapeutics, Inc. |
pancrelipase lipase, pancrelipase protease, pancrelipase amylase |
D05349
|
|
Oxygen gas 99 L00L (NDA)
|
MAVERICK OXYGEN & RESPIRATORY EQUIPMENT, LLC |
Oxygen |
D00003
|
|
Lidocaine ointment 50 mg/g (ANDA)
|
Preferred Pharmaceuticals Inc. |
Lidocaine |
D00358
|
|
Nitrogen gas 990 mL/L (NDA)
|
Roberts Oxygen Company, Inc |
Nitrogen |
D00083
|
|
Carbon Dioxide gas 990 mL/L (NDA)
|
Keen Compressed Gas Co. Inc. |
Carbon Dioxide |
D00004
|
|
Helium gas 990 mL/L (NDA)
|
Keen Compressed Gas Co. Inc. |
Helium |
D04420
|
|
Doxycycline Hyclate capsule 100 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Doxycycline Hyclate |
D02129
|
|
Naltrexone Hydrochloride tablet, film coated 50 mg (ANDA)
|
Bryant Ranch Prepack |
Naltrexone Hydrochloride |
D02095
|
|
Nortriptyline Hydrochloride capsule 75 mg (ANDA)
|
Bryant Ranch Prepack |
Nortriptyline Hydrochloride |
D00816
|
|
PRAVASTATIN SODIUM tablet 80 mg (ANDA)
|
Bryant Ranch Prepack |
PRAVASTATIN SODIUM |
D00893
|
|
Indomethacin capsule 50 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Indomethacin |
D00141
|
|
Intralipid emulsion 30 g00mL (NDA)
|
Fresenius Kabi USA, LLC |
I.V. Fat Emulsion |
D04962
|
|
Nitrous Oxide gas 990 mL/L (NDA)
|
Roberts Oxygen Company, Inc. |
Nitrous Oxide |
D00102
|
Cyclophosphamide injection, powder, for solution 500 mg/25mL (ANDA)
Cyclophosphamide injection, powder, for solution 1 g/50mL (ANDA)
Cyclophosphamide injection, powder, for solution 2 g00mL (ANDA)
|
Epic Pharma, LLC |
cyclophosphamide |
D00287
|
|
Nitrous Oxide gas 990 mL/L (NDA)
|
MAVERICK OXYGEN & RESPIRATORY EQUIPMENT, LLC |
Nitrous Oxide |
D00102
|
Dexamethasone tablet 4 mg (ANDA)
Dexamethasone tablet 6 mg (ANDA)
|
Alvogen Inc. |
dexamethasone |
D00292
|
|
Oxygen gas 995 mL/L (NDA)
|
Messer Gas Puerto Rico, Inc |
Oxygen |
D00003
|
Perphenazine tablet, film coated 4 mg (ANDA)
Perphenazine tablet, film coated 8 mg (ANDA)
|
American Health Packaging |
perphenazine |
D00503
|
|
Azelastine Hydrochloride spray, metered 137 ug (ANDA)
|
Preferred Pharmaceuticals Inc. |
azelastine hydrochloride |
D00659
|
|
Nitrogen gas 995 mL/L (NDA)
|
Messer Gas Puerto Rico, Inc |
Nitrogen |
D00083
|
|
Propafenone Hydrochloride tablet, coated 300 mg (ANDA)
|
Bryant Ranch Prepack |
Propafenone Hydrochloride |
D00640
|
|
Nitrous Oxide gas 990 mL/L (NDA)
|
Roberts Oxygen Company, Inc. |
Nitrous Oxide |
D00102
|
|
KOURZEQ paste 1 mg/g (ANDA)
|
MidAmerica Pharmaceuticals |
Triamcinolone Acetonide |
D00983
|
|
OXYGEN gas 99 L00L (NDA)
|
Keen Compressed Gas Co. Inc. |
OXYGEN |
D00003
|
|
Oxygen gas 990 mL/L (NDA)
|
Roberts Oxygen Company, Inc. |
Oxygen |
D00003
|
|
Naltrexone Hydrochloride tablet, film coated 50 mg (ANDA)
|
Bryant Ranch Prepack |
Naltrexone Hydrochloride |
D02095
|
|
Carbon Dioxide-Oxygen Mixture gas 70 mL/L (NDA)
|
Roberts Oxygen Company, Inc. |
Carbon Dioxide-Oxygen Mixture |
|
|
Diclofenac Sodium tablet, delayed release 75 mg (ANDA)
|
SOLA Pharmaceuticals, LLC |
Diclofenac Sodium |
D00904
|
|
Nitrogen gas 999 mL/L (NDA)
|
Delille Oxygen Company |
Nitrogen |
D00083
|
|
Carbon Dioxide-Oxygen Mixture gas 200 mL/L (NDA)
|
Roberts Oxygen Company, Inc. |
Carbon Dioxide-Oxygen Mixture |
|
Levetiracetam tablet, film coated 500 mg (ANDA)
Levetiracetam tablet, film coated 1000 mg (ANDA)
|
A-S Medication Solutions |
Levetiracetam |
D00709
|
|
Clindamycin Phosphate solution 10 mg/mL (ANDA)
|
A-S Medication Solutions |
Clindamycin Phosphate |
D01073
|
|
Mirtazapine tablet, film coated 7.5 mg (ANDA)
|
Bryant Ranch Prepack |
Mirtazapine |
D00563
|
|
Intralipid emulsion 20 g00mL (NDA)
|
Fresenius Kabi USA, LLC |
I.V. Fat Emulsion |
D04962
|
|
Carbon Dioxide-Air Mixture gas 80 mL/L (NDA)
|
Roberts Oxygen Company, Inc. |
Carbon Dioxide-Air Mixture |
|
METADATE CD capsule, extended release 10 mg (NDA)
METADATE CD capsule, extended release 20 mg (NDA)
METADATE CD capsule, extended release 30 mg (NDA)
METADATE CD capsule, extended release 40 mg (NDA)
METADATE CD capsule, extended release 50 mg (NDA)
METADATE CD capsule, extended release 60 mg (NDA)
|
Aytu BioPharma, Inc. |
methylphenidate hydrochloride |
D01296
|
|
Mirtazapine tablet, film coated 15 mg (ANDA)
|
Bryant Ranch Prepack |
Mirtazapine |
D00563
|
|
Sumatriptan injection, solution 6 mg/.5mL (ANDA)
|
Eugia US LLC |
Sumatriptan |
D00676
|
|
Gadobutrol injection 604.72 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
Gadobutrol |
D07420
|