| Product |
Company |
Generic name |
KEGG DRUG |
Detrol tablet, film coated 1 mg (NDA)
Detrol tablet, film coated 2 mg (NDA)
|
Viatris Specialty LLC |
tolterodine tartrate |
D01148
|
|
BRIDION injection, solution 100 mg/mL (NDA)
|
Merck Sharp & Dohme LLC |
sugammadex |
D05940
|
SECUADO film, extended release 3.8 mg/d (NDA)
SECUADO film, extended release 5.7 mg/d (NDA)
SECUADO film, extended release 7.6 mg/d (NDA)
|
Noven Therapeutics, LLC |
ASENAPINE |
D11769
|
Sitagliptin tablet 25 mg (NDA AUTHORIZED GENERIC)
Sitagliptin tablet 50 mg (NDA AUTHORIZED GENERIC)
Sitagliptin tablet 100 mg (NDA AUTHORIZED GENERIC)
|
Zydus Pharmaceuticals (USA) Inc. |
Sitagliptin |
D08516
|
Levetiracetam tablet 250 mg (ANDA)
Levetiracetam tablet 500 mg (ANDA)
Levetiracetam tablet 750 mg (ANDA)
Levetiracetam tablet 1000 mg (ANDA)
|
Torrent Pharmaceuticals Limited |
Levetiracetam |
D00709
|
|
Docetaxel injection, solution 20 mg/mL (NDA)
|
Hospira, Inc. |
DOCETAXEL |
D02165
|
|
Xelria Fe kit (ANDA)
|
Xiromed LLC |
norethindrone and ethinyl estradiol and ferrous fumarate |
D04483
|
|
Methylphenidate Hydrochloride tablet, extended release 72 mg (ANDA)
|
Northstar Rx LLC |
Methylphenidate Hydrochloride |
D01296
|
Penicillin G Potassium injection, powder, for solution 5000000 [iU] (ANDA)
Penicillin G Potassium injection, powder, for solution 20000000 [iU] (ANDA)
|
Avenacy Inc. |
penicillin g potassium |
D01053
|
ZITUVIO tablet 25 mg (NDA)
ZITUVIO tablet 50 mg (NDA)
ZITUVIO tablet 100 mg (NDA)
|
Zydus Pharmaceuticals (USA) Inc. |
Sitagliptin |
D08516
|
ZITUVIO tablet 25 mg (NDA)
ZITUVIO tablet 50 mg (NDA)
ZITUVIO tablet 100 mg (NDA)
|
Zydus Lifesciences Limited |
Sitagliptin |
D08516
|
ABILIFY tablet 2 mg (NDA)
ABILIFY tablet 5 mg (NDA)
ABILIFY tablet 10 mg (NDA)
ABILIFY tablet 15 mg (NDA)
ABILIFY tablet 20 mg (NDA)
ABILIFY tablet 30 mg (NDA)
|
Otsuka America Pharmaceutical, Inc. |
ARIPIPRAZOLE |
D01164
|
|
POSACONAZOLE solution 18 mg/mL (ANDA)
|
Camber Pharmaceuticals, Inc. |
POSACONAZOLE |
D02555
|
Arixtra injection, solution 2.5 mg/.5mL (NDA)
Arixtra injection, solution 5 mg/.4mL (NDA)
Arixtra injection, solution 7.5 mg/.6mL (NDA)
Arixtra injection, solution 10 mg/.8mL (NDA)
|
Mylan Institutional LLC |
fondaparinux sodium |
D01844
|
Esomeprazole Magnesium capsule, delayed release 40 mg (ANDA)
Esomeprazole Magnesium capsule, delayed release 20 mg (ANDA)
|
Amneal Pharmaceuticals LLC |
Esomeprazole Magnesium |
D01984
|
|
FEIRZA 1.5/30 TM kit (ANDA)
|
Xiromed LLC |
Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1.5 mg/30 mcg and Ferrous Fumarate Tablets, 75 mg |
D04483
|
|
Halcinonide Topical Solution solution 1 mg/mL (ANDA)
|
INA Pharmaceutics Inc |
Halcinonide Topical |
D01308
|
Sitagliptin tablet 25 mg (NDA AUTHORIZED GENERIC)
Sitagliptin tablet 50 mg (NDA AUTHORIZED GENERIC)
Sitagliptin tablet 100 mg (NDA AUTHORIZED GENERIC)
|
Zydus Lifesciences Limited |
Sitagliptin |
D08516
|
Abiraterone Acetate tablet, film coated 250 mg (ANDA)
Abiraterone Acetate tablet, film coated 500 mg (ANDA)
|
Novugen Pharma (USA) LLC |
abiraterone acetate |
D09701
|
|
FEIRZA 1/20 kit (ANDA)
|
Xiromed LLC |
Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg |
D04483
|
|
Bupropion Hydrochloride tablet, extended release 150 mg (ANDA)
|
A-S Medication Solutions |
Bupropion Hydrochloride |
D00817
|
|
Amoxicillin tablet, coated 875 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Amoxicillin |
D00229
|
|
Liraglutide injection 6 mg/mL (NDA AUTHORIZED GENERIC)
|
A-S Medication Solutions |
liraglutide |
D06404
|
|
CLEOCIN PHOSPHATE injection, solution 150 mg/mL (NDA)
|
Henry Schein, Inc. |
clindamycin phosphate |
D01073
|
|
Diclofenac Sodium tablet, delayed release 75 mg (ANDA)
|
Coupler LLC |
Diclofenac Sodium |
D00904
|
|
Diltiazem Hydrochloride capsule, extended release 120 mg (ANDA)
|
Coupler LLC |
diltiazem hydrochloride |
D00616
|
|
Methocarbamol tablet 750 mg (ANDA)
|
Coupler LLC |
Methocarbamol |
D00402
|
|
levofloxacin tablet, film coated 250 mg (ANDA)
|
Coupler LLC |
levofloxacin |
D00588
|
AMPICILLIN powder, for solution 250 mg/250mg (ANDA)
AMPICILLIN powder, for solution 500 mg/500mg (ANDA)
AMPICILLIN powder, for solution 1 g/g (ANDA)
AMPICILLIN powder, for solution 2 g/2g (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
Ampicillin Injection |
D02119
|
|
Pantoprazole Sodium injection, powder, lyophilized, for solution 40 mg0mL (ANDA)
|
Fresenius Kabi USA, LLC |
Pantoprazole Sodium |
D02593
|
|
Zolpidem Tartrate tablet, film coated 5 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Zolpidem Tartrate |
D00706
|
|
ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE capsule, extended release 25 mg (ANDA)
|
Bryant Ranch Prepack |
ASPIRIN and Extended-Release DIPYRIDAMOLE |
D11615
|
Prochlorperazine Maleate tablet 5 mg (ANDA)
Prochlorperazine Maleate tablet 10 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Prochlorperazine Maleate |
D00479
|
|
HICON solution 1000 mCi/mL (NDA)
|
Jubilant DraxImage Inc., dba Jubilant Radiopharma |
Sodium Iodide I 131 |
D02259
|
Piroxicam capsule 10 mg (ANDA)
Piroxicam capsule 20 mg (ANDA)
|
Strides Pharma Science Limited |
Piroxicam |
D00127
|
|
Bupropion Hydrochloride tablet, extended release 150 mg (ANDA)
|
A-S Medication Solutions |
Bupropion Hydrochloride |
D00817
|
|
Theophylline solution 80 mg5mL (ANDA)
|
Cranbury Pharmaceuticals, LLC |
Theophylline |
D00371
|
Gabapentin capsule 400 mg (ANDA)
Gabapentin capsule 100 mg (ANDA)
Gabapentin capsule 300 mg (ANDA)
|
Strides Pharma Science Limited |
Gabapentin |
D00332
|
|
Dicyclomine Hydrochloride capsule 10 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Dicyclomine Hydrochloride |
D00717
|
|
IDkit HP ONE solution 4 g (NDA)
|
Meridian Bioscience Israel Ltd |
citric acid anhydrous and 13C urea |
|