Product |
Company |
Generic name |
KEGG DRUG |
GlucaGen injection, powder, for solution 1 mg/mL (NDA)
GlucaGen kit (NDA)
|
Boehringer Ingelheim Pharmaceuticals, Inc.
|
glucagon hydrochloride
|
D02118
|
Azithromycin tablet, film coated 500 mg (ANDA)
|
Preferred Pharmaceuticals Inc.
|
Azithromycin
|
D02134
|
Trazodone Hydrochloride tablet 50 mg (ANDA)
|
Quality Care Products, LLC
|
Trazodone Hydrochloride
|
D00820
|
Tadalafil tablet, film coated 2.5 mg (ANDA)
|
Bryant Ranch Prepack
|
Tadalafil
|
D02008
|
NALOXONE HYDROCHLORIDE injection, solution .4 mg/mL (ANDA)
|
General Injectables and Vaccines, INC.
|
naloxone hydrochloride
|
D01340
|
metronidazole tablet 250 mg (ANDA)
|
Bryant Ranch Prepack
|
metronidazole
|
D00409
|
Morphine Sulfate tablet 15 mg (NDA)
|
Lake Erie Medical DBA Quality Care Products LLC
|
Morphine Sulfate
|
D00842
|
Exforge HCT tablet, film coated 5 mg (NDA)
Exforge HCT tablet, film coated 10 mg (NDA)
|
Novartis Pharmaceuticals Corporation
|
amlodipine valsartan and hydrochlorothiazide
|
D10286
|
Morphine Sulfate Extended Release tablet, film coated, extended release 15 mg (ANDA)
Morphine Sulfate Extended Release tablet, film coated, extended release 30 mg (ANDA)
Morphine Sulfate Extended Release tablet, film coated, extended release 60 mg (ANDA)
Morphine Sulfate Extended Release tablet, film coated, extended release 100 mg (ANDA)
Morphine Sulfate Extended Release tablet, film coated, extended release 200 mg (ANDA)
|
Rhodes Pharmaceuticals L. P.
|
Morphine Sulfate
|
D00842
|
Naproxen tablet 500 mg (ANDA)
|
Quality Care Products, LLC
|
Naproxen
|
D00118
|
Fomepizole injection, solution 1 g/mL (ANDA)
|
Zydus Pharmaceuticals USA Inc.
|
Fomepizole
|
D00707
|
Azithromycin tablet, film coated 500 mg (ANDA)
|
Preferred Pharmaceuticals Inc.
|
Azithromycin
|
D06390
|
ZOLPIDEM TARTRATE tablet 5 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc.
|
zolpidem tartrate
|
D00706
|
levothyroxine sodium tablet 125 ug (NDA)
|
Proficient Rx LP
|
levothyroxine sodium
|
D01010
|
Cartia XT capsule, extended release 120 mg (ANDA)
Cartia XT capsule, extended release 180 mg (ANDA)
Cartia XT capsule, extended release 240 mg (ANDA)
Cartia XT capsule, extended release 300 mg (ANDA)
|
Actavis Pharma, Inc.
|
Diltiazem Hydrochloride
|
D00616
|
Pepaxto injection, powder, lyophilized, for solution 20 mg/50mL (NDA)
|
Oncopeptides, AB
|
melphalan flufenamide
|
D11870
|
Epitol tablet 200 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc.
|
Carbamazepine
|
D00252
|
Hydralazine Hydrochloride tablet, film coated 10 mg (ANDA)
Hydralazine Hydrochloride tablet, film coated 50 mg (ANDA)
Hydralazine Hydrochloride tablet, film coated 25 mg (ANDA)
|
Cardinal Health
|
Hydralazine Hydrochloride
|
D01302
|
Ceftriaxone Sodium injection, powder, for solution 1 g (ANDA)
|
Proficient Rx LP
|
Ceftriaxone Sodium
|
D00924
|
telmisartan tablet 40 mg (ANDA)
|
Bryant Ranch Prepack
|
telmisartan
|
D00627
|
Methotrexate tablet 2.5 mg (ANDA)
|
Bryant Ranch Prepack
|
Methotrexate
|
D02115
|
voriconazole tablet, film coated 50 mg (ANDA)
voriconazole tablet, film coated 200 mg (ANDA)
|
Glenmark Pharmaceuticals Inc., USA
|
voriconazole
|
D00578
|
Diphenhydramine Hydrochloride injection, solution 50 mg/mL (ANDA)
|
General Injectables & Vaccines, Inc
|
Diphenhydramine Hydrochloride
|
D00669
|
Meloxicam tablet 7.5 mg (ANDA)
Meloxicam tablet 15 mg (ANDA)
|
XLCare Pharmaceuticals, Inc.
|
Meloxicam
|
D00969
|
CLOZAPINE tablet 25 mg (ANDA)
CLOZAPINE tablet 50 mg (ANDA)
CLOZAPINE tablet 100 mg (ANDA)
CLOZAPINE tablet 200 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc.
|
CLOZAPINE
|
D00283
|
Ibuprofen tablet 400 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC
|
Ibuprofen
|
D00126
|
Sildenafil tablet, film coated 50 mg (ANDA)
|
Proficient Rx LP
|
Sildenafil
|
D02229
|
Pioglitazone Hydrochloride tablet 45 mg (ANDA)
|
A-S Medication Solutions
|
PIOGLITAZONE
|
D00945
|
ketorolac tromethamine injection, solution 15 mg/mL (ANDA)
ketorolac tromethamine injection, solution 30 mg/mL (ANDA)
|
Gland Pharma Limited
|
ketorolac tromethamine
|
D00813
|
Benzhydrocodone and Acetaminophen tablet 4.08 mg (NDA AUTHORIZED GENERIC)
Benzhydrocodone and Acetaminophen tablet 6.12 mg (NDA AUTHORIZED GENERIC)
Benzhydrocodone and Acetaminophen tablet 8.16 mg (NDA AUTHORIZED GENERIC)
|
KVK-Tech, Inc.
|
Benzhydrocodone and Acetaminophen
|
D11628
|
AMINOCAPROIC ACID solution .25 g/mL (ANDA)
|
Leading Pharma, LLC
|
AMINOCAPROIC ACID
|
D00160
|
Azithromycin tablet, film coated 250 mg (ANDA)
|
Preferred Pharmaceuticals, Inc.
|
Azithromycin
|
D02134
|
Hydroxyzine Hydrochloride tablet, film coated 50 mg (ANDA)
|
Proficient Rx LP
|
Hydroxyzine Hydrochloride
|
D00672
|
Zolgensma kit (BLA)
|
AveXis, Inc.
|
onasemnogene abeparvovec-xioi
|
D11559
|
Ketoprofen capsule 25 mg (ANDA)
|
Sterling-Knight Pharmaceuticals LLC
|
Ketoprofen
|
D00132
|
FOSAPREPITANT injection, powder, lyophilized, for solution 150 mg/5mL (ANDA)
|
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
|
FOSAPREPITANT DIMEGLUMINE
|
D06597
|
Ibuprofen tablet 800 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC
|
Ibuprofen
|
D00126
|
Amoxicillin capsule 500 mg (ANDA)
|
Lake Erie Medical DBA Quality Care Products LLC
|
Amoxicillin
|
D00229
|
Butrans patch, extended release 5 ug/h (NDA)
Butrans patch, extended release 10 ug/h (NDA)
Butrans patch, extended release 20 ug/h (NDA)
Butrans patch, extended release 15 ug/h (NDA)
Butrans patch, extended release 7.5 ug/h (NDA)
|
Purdue Pharma LP
|
buprenorphine
|
D07132
|
Pantoprazole Sodium tablet, delayed release 40 mg (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Pantoprazole Sodium
|
D02593
|