| Product |
Company |
Generic name |
KEGG DRUG |
NICARDIPINE HYDROCHLORIDE injection .1 mg/mL (ANDA)
NICARDIPINE HYDROCHLORIDE injection .2 mg/mL (ANDA)
|
Cipla USA Inc. |
nicardipine hydrochloride |
D00617
|
|
METOPROLOL TARTRATE tablet, film coated 100 mg (ANDA)
|
REMEDYREPACK INC. |
METOPROLOL TARTRATE |
D00601
|
|
Scopolamine patch, extended release 1 mg/3d (ANDA)
|
Bryant Ranch Prepack |
Scopolamine |
D00138
|
|
Darifenacin tablet, extended release 15 mg (ANDA)
|
Bryant Ranch Prepack |
Darifenacin |
D01699
|
|
CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated 5 mg (ANDA)
|
REMEDYREPACK INC. |
cyclobenzaprine hydrochloride |
D00772
|
|
Probenecid tablet, film coated 500 mg (ANDA)
|
Marlex Pharmaceuticals Inc |
Probenecid |
D00475
|
BUPROPION HYDROCHLORIDE tablet, film coated, extended release 100 mg (ANDA)
BUPROPION HYDROCHLORIDE tablet, film coated, extended release 150 mg (ANDA)
BUPROPION HYDROCHLORIDE tablet, film coated, extended release 200 mg (ANDA)
|
Granules Pharmaceuticals Inc. |
bupropion hydrochloride |
D00817
|
|
LEMTRADA injection, solution, concentrate 12 mg.2mL (BLA)
|
Genzyme Corporation |
ALEMTUZUMAB |
D02802
|
DASATINIB tablet, film coated 20 mg (ANDA)
DASATINIB tablet, film coated 50 mg (ANDA)
DASATINIB tablet, film coated 70 mg (ANDA)
DASATINIB tablet, film coated 80 mg (ANDA)
DASATINIB tablet, film coated 100 mg (ANDA)
DASATINIB tablet, film coated 140 mg (ANDA)
|
Alembic Pharmaceuticals Limited |
DASATINIB |
D06414
|
|
HYDROCHLOROTHIAZIDE tablet 12.5 mg (ANDA)
|
A-S Medication Solutions |
hydrochlorothiazide |
D00340
|
|
Oxycodone Hydrochloride solution 5 mg/5mL (NDA)
|
Genus Lifesciences Inc. |
Oxycodone Hydrochloride |
D00847
|
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)
|
Solco Healthcare US,LLC |
Lisdexamfetamine dimesylate capsules |
D04747
|
|
Darifenacin tablet, extended release 7.5 mg (ANDA)
|
Bryant Ranch Prepack |
Darifenacin |
D01699
|
|
Carbon Dioxide-Air Mixture gas 50 mL/L (NDA)
|
Roberts Oxygen Company, Inc. |
Carbon Dioxide-Air Mixture |
|
|
Lactated Ringers and Dextrose injection, solution 20 mg00mL (NDA)
|
Baxter Healthcare Corporation |
SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE and DEXTROSE MONOHYDRATE |
|
|
Minocycline Hydrochloride capsule 100 mg (ANDA)
|
Bryant Ranch Prepack |
Minocycline Hydrochloride |
D00850
|
RYTARY capsule, extended release 23.75 mg (NDA)
RYTARY capsule, extended release 36.25 mg (NDA)
RYTARY capsule, extended release 48.75 mg (NDA)
RYTARY capsule, extended release 61.25 mg (NDA)
|
Amneal Pharmaceuticals LLC |
Carbidopa and Levodopa |
D00253
|
|
Carbon Dioxide-Air Mixture gas 70 mL/L (NDA)
|
Roberts Oxygen Company, Inc. |
Carbon Dioxide-Air Mixture |
|
|
Acyclovir tablet 800 mg (ANDA)
|
REMEDYREPACK INC. |
Acyclovir |
D00222
|
|
Carbon Dioxide gas 990 mL/L (NDA)
|
Red Ball Oxygen Co., Inc. |
Carbon Dioxide |
D00004
|
Tracleer tablet, film coated 62.5 mg (NDA)
Tracleer tablet, film coated 125 mg (NDA)
Tracleer tablet, for suspension 32 mg (NDA)
|
Actelion Pharmaceuticals US, Inc. |
bosentan |
D01227
|
|
OXYGEN gas 995 mL/L (NDA)
|
CEE-KAY SUPPLY, INC. |
OXYGEN |
D00003
|
|
DAPTOMYCIN injection, powder, lyophilized, for solution 500 mg0mL (ANDA)
|
Meitheal Pharmaceuticals Inc. |
DAPTOMYCIN |
D01080
|
|
Tigan injection 100 mg/mL (NDA)
|
Par Health USA, LLC |
trimethobenzamide hydrochloride |
D02733
|
Zenpep capsule, delayed release 14000 [USP'U] (BLA)
Zenpep capsule, delayed release 42000 [USP'U] (BLA)
Zenpep capsule, delayed release 63000 [USP'U] (BLA)
Zenpep capsule, delayed release 84000 [USP'U] (BLA)
Zenpep capsule, delayed release 168000 [USP'U] (BLA)
Zenpep capsule, delayed release 24000 [USP'U] (BLA)
Zenpep capsule, delayed release 105000 [USP'U] (BLA)
Zenpep capsule, delayed release 252600 [USP'U] (BLA)
|
Aimmune Therapeutics, Inc. |
pancrelipase lipase, pancrelipase protease, pancrelipase amylase |
D05349
|
Oseltamivir Phosphate capsule 30 mg (ANDA)
Oseltamivir Phosphate capsule 45 mg (ANDA)
Oseltamivir Phosphate capsule 75 mg (ANDA)
|
Alvogen Inc. |
Oseltamivir phosphate |
D00900
|
|
Oxygen gas 99 L00L (NDA)
|
MAVERICK OXYGEN & RESPIRATORY EQUIPMENT, LLC |
Oxygen |
D00003
|
|
Lidocaine and Prilocaine cream 25 mg/g (ANDA)
|
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. |
lidocaine and prilocaine |
D02740
|
Mycophenolic Acid tablet, delayed release 180 mg (ANDA)
Mycophenolic Acid tablet, delayed release 360 mg (ANDA)
|
Biocon Pharma Inc. |
Mycophenolic Acid |
D05095
|
|
Lidocaine ointment 50 mg/g (ANDA)
|
Preferred Pharmaceuticals Inc. |
Lidocaine |
D00358
|
|
Nitrogen gas 992 mL/L (NDA)
|
Red Ball Oxygen Co., Inc. |
Nitrogen |
D00083
|
|
Nitrogen gas 990 mL/L (NDA)
|
Roberts Oxygen Company, Inc |
Nitrogen |
D00083
|
|
Ibuprofen tablet, film coated 800 mg (ANDA)
|
St. Mary's Medical Park Pharmacy |
Ibuprofen |
D00126
|
|
Diclofenac Sodium tablet, extended release 100 mg (ANDA)
|
Lannett Company, Inc. |
Diclofenac Sodium |
D00904
|
|
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
|
|
Scopolamine patch, extended release 1 mg/3d (ANDA)
|
Bryant Ranch Prepack |
Scopolamine |
D00138
|
|
Naltrexone Hydrochloride tablet, film coated 50 mg (ANDA)
|
Bryant Ranch Prepack |
Naltrexone Hydrochloride |
D02095
|
|
Ondansetron solution 4 mg/5mL (ANDA)
|
American Health Packaging |
Ondansetron |
D00678
|