| Product |
Company |
Generic name |
KEGG DRUG |
Lisdexamfetamine Dimesylate capsule 10 mg (ANDA)
Lisdexamfetamine Dimesylate capsule 20 mg (ANDA)
Lisdexamfetamine Dimesylate capsule 30 mg (ANDA)
Lisdexamfetamine Dimesylate capsule 40 mg (ANDA)
Lisdexamfetamine Dimesylate capsule 50 mg (ANDA)
Lisdexamfetamine Dimesylate capsule 60 mg (ANDA)
Lisdexamfetamine Dimesylate capsule 70 mg (ANDA)
|
Elite Laboratories, Inc. |
lisdexamfetamine dimesylate |
D04747
|
Dabigatran Etexilate capsule 75 mg (ANDA)
Dabigatran Etexilate capsule 150 mg (ANDA)
Dabigatran Etexilate capsule 110 mg (ANDA)
|
Alembic Pharmaceuticals Limited |
Dabigatran Etexilate |
D07082
|
|
Lamotrigine tablet 100 mg (ANDA)
|
REMEDYREPACK INC. |
Lamotrigine |
D00354
|
|
FLUOROURACIL injection, solution 50 mg/mL (ANDA)
|
Eugia US LLC |
FLUOROURACIL |
D00584
|
|
Mirtazapine tablet, film coated 45 mg (ANDA)
|
REMEDYREPACK INC. |
Mirtazapine |
D00563
|
|
Oseltamivir phosphate capsule 45 mg (ANDA)
|
MSN LABORATORIES PRIVATE LIMITED |
Oseltamivir phosphate |
D00900
|
|
OXYGEN gas 99 L00L (NDA)
|
Johnson Drug Company, Inc |
OXYGEN |
D00003
|
|
Mirtazapine tablet, film coated 15 mg (ANDA)
|
Bryant Ranch Prepack |
Mirtazapine |
D00563
|
|
Nitrogen gas 992 mL/L (NDA)
|
Victor Welding Supply Company |
Nitrogen |
D00083
|
ANTARA capsule 43 mg (NDA)
ANTARA capsule 130 mg (NDA)
|
Lupin Pharmaceuticals, Inc. |
FENOFIBRATE |
D00565
|
|
Nitrous Oxide gas 990 mL/L (NDA)
|
FULLERTON WELDING SUPPLY |
Nitrous Oxide |
D00102
|
|
Oxygen gas 990 mL/L (NDA)
|
FULLERTON WELDING SUPPLY |
Oxygen |
D00003
|
|
AHZANTIVE injection, solution 40 mg/mL (BLA)
|
Valorum Biologics, LLC |
aflibercept-mrbb |
D09574
|
|
Macrobid capsule 25 mg (NDA)
|
REMEDYREPACK INC. |
Nitrofurantoin Monohydrate/Macrocrystalline |
D00439
|
Ropinirole tablet, extended release 2 mg (ANDA)
Ropinirole tablet, extended release 4 mg (ANDA)
Ropinirole tablet, extended release 6 mg (ANDA)
Ropinirole tablet, extended release 8 mg (ANDA)
Ropinirole tablet, extended release 12 mg (ANDA)
|
Elite Laboratories, Inc. |
Ropinirole |
D00784
|
Ropinirole tablet, film coated .25 mg (ANDA)
Ropinirole tablet, film coated .5 mg (ANDA)
Ropinirole tablet, film coated 1 mg (ANDA)
Ropinirole tablet, film coated 2 mg (ANDA)
Ropinirole tablet, film coated 3 mg (ANDA)
Ropinirole tablet, film coated 4 mg (ANDA)
Ropinirole tablet, film coated 5 mg (ANDA)
|
Marlex Pharmaceuticals Inc |
ropinirole |
D00784
|
|
VORICONAZOLE injection, solution 10 mg/mL (ANDA)
|
Hainan Poly Pharm. Co., Ltd. |
VORICONAZOLE |
D00578
|
|
VAXELIS injection, suspension 20 ug/.5mL (BLA)
|
MSP Vaccine Company |
diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine |
|
|
Tranexamic Acid tablet, film coated 650 mg (ANDA)
|
Actavis Pharma, Inc. |
Tranexamic Acid |
D01136
|
Furosemide injection, solution 20 mg/2mL (ANDA)
Furosemide injection, solution 40 mg/4mL (ANDA)
Furosemide injection, solution 100 mg0mL (ANDA)
|
Eugia US LLC |
Furosemide |
D00331
|
|
Lidocaine Hydrochloride injection, solution 20 mg/mL (ANDA)
|
ProPharma Distribution |
Lidocaine Hydrochloride |
D02086
|
|
Phenytoin Sodium injection 50 mg/mL (ANDA)
|
ProPharma Distribution |
Phenytoin Sodium |
D02103
|
|
Pantoprazole Sodium tablet, delayed release 20 mg (ANDA)
|
PHOENIX RX LLC |
Pantoprazole |
D02593
|
ampicillin sodium and sulbactam sodium injection, powder, for solution 1 g (ANDA)
ampicillin sodium and sulbactam sodium injection, powder, for solution 2 g (ANDA)
|
ONESOURCE SPECIALTY PHARMA LIMITED |
ampicillin sodium and sulbactam sodium |
D02065
|
|
Carvedilol tablet, film coated 3.125 mg (ANDA)
|
Coupler LLC |
Carvedilol |
D00255
|
|
Cleocin T lotion 10 mg/mL (NDA)
|
Pharmacia & Upjohn Company LLC |
clindamycin phosphate |
D01073
|
|
OXCARBAZEPINE tablet, film coated 300 mg (ANDA)
|
REMEDYREPACK INC. |
OXCARBAZEPINE |
D00533
|
ACETAZOLAMIDE tablet 125 mg (ANDA)
ACETAZOLAMIDE tablet 250 mg (ANDA)
|
Aurobindo Pharma Limited |
ACETAZOLAMIDE |
D00218
|
RIVAROXABAN kit (ANDA)
RIVAROXABAN tablet, film coated 10 mg (ANDA)
RIVAROXABAN tablet, film coated 15 mg (ANDA)
RIVAROXABAN tablet, film coated 20 mg (ANDA)
RIVAROXABAN tablet, film coated 2.5 mg (ANDA)
|
Alembic Pharmaceuticals Limited |
RIVAROXABAN |
D07086
|
|
TICAGRELOR tablet, film coated 90 mg (ANDA)
|
Solco Healthcare U.S., LLC |
ticagrelor |
D09017
|
|
BUSULFEX injection 6 mg/mL (NDA)
|
Otsuka America Pharmaceutical, Inc. |
busulfan |
D00248
|
Leflunomide tablet, film coated 10 mg (ANDA)
Leflunomide tablet, film coated 20 mg (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Leflunomide |
D00749
|
|
Naltrexone Hydrochloride tablet, film coated 50 mg (ANDA)
|
TAGI Pharma Inc. |
Naltrexone Hydrochloride |
D02095
|
|
Levetiracetam tablet, film coated 750 mg (ANDA)
|
A-S Medication Solutions |
Levetiracetam |
D00709
|
|
Nitrofurantoin Oral Suspension suspension 25 mg/5mL (ANDA)
|
PAI Holdings, LLC dba PAI Pharma |
Nitrofurantoin Oral Suspension |
D00439
|
|
Manganese injection, solution .1 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
Manganese |
D04852
|
|
ProQuad injection, powder, lyophilized, for suspension 1000 [TCID_50]/.5mL (BLA)
|
Merck Sharp & Dohme LLC |
Measles, Mumps, Rubella and Varicella Virus Vaccine Live |
|
OXYCODONE HYDROCHLORIDE solution 100 mg/5mL (ANDA)
Oxycodone Hydrochloride solution 5 mg/5mL (ANDA)
|
KVK-Tech, Inc. |
oxycodone hydrochloride |
D00847
|
|
Nitrogen gas 990 mL/L (NDA)
|
FULLERTON WELDING SUPPLY |
Nitrogen |
D00083
|
|
Nitrogen gas 990 mL/L (NDA)
|
FULLERTON WELDING SUPPLY |
Nitrogen |
D00083
|