| Product |
Company |
Generic name |
KEGG DRUG |
Azithromycin powder, for suspension 100 mg/5mL (ANDA)
Azithromycin powder, for suspension 200 mg/5mL (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
Azithromycin |
D02134
|
|
Esomeprazole Magnesium capsule, delayed release 20 mg (ANDA)
|
American Health Packaging |
Esomeprazole Magnesium |
D01984
|
|
Clonazepam tablet .5 mg (ANDA)
|
REMEDYREPACK INC. |
Clonazepam |
D00280
|
|
Verapamil Hydrochloride injection 2.5 mg/mL (ANDA)
|
Micro Labs Limited |
Verapamil Hydrochloride |
D00619
|
|
Levofloxacin tablet, film coated 500 mg (ANDA)
|
REMEDYREPACK INC. |
Levofloxacin |
D00588
|
|
Bumetanide tablet 1 mg (ANDA)
|
Major Pharmaceuticals |
Bumetanide |
D00247
|
|
Ritonavir tablet 100 mg (ANDA)
|
Amneal Pharmaceuticals LLC |
Ritonavir |
D00427
|
|
Ascorbic Acid injection 500 mg/mL (ANDA)
|
Renova Pharmaceuticals LLC |
Ascorbic Acid |
D00018
|
|
Tranexamic Acid injection, solution 100 mg/mL (ANDA)
|
Apotex Corp. |
tranexamic acid |
D01136
|
|
Primidone tablet 250 mg (ANDA)
|
Actavis Pharma, Inc. |
Primidone |
D00474
|
|
Bilprevda injection, solution 120 mg.7mL (BLA)
|
Organon LLC |
Denosumab |
D03684
|
|
Ocrevus Zunovo injection, solution 920 mg/23mL (BLA)
|
Genentech, Inc. |
ocrelizumab and hyaluronidase |
D05218
|
|
BILDYOS injection, solution 60 mg/mL (BLA)
|
Organon LLC |
Denosumab |
D03684
|
DELFLEX solution 1.5 g00mL (NDA)
DELFLEX solution 538 mg00mL (NDA)
DELFLEX solution 4.25 g00mL (NDA)
|
Fresenius Medical Care Renal Therapies Group, LLC |
Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride |
|
|
Divalproex sodium tablet, film coated, extended release 500 mg (ANDA)
|
REMEDYREPACK INC. |
Divalproex sodium |
D00304
|
Perampanel tablet, film coated 2 mg (ANDA)
Perampanel tablet, film coated 4 mg (ANDA)
Perampanel tablet, film coated 6 mg (ANDA)
Perampanel tablet, film coated 8 mg (ANDA)
Perampanel tablet, film coated 10 mg (ANDA)
Perampanel tablet, film coated 12 mg (ANDA)
|
Teva Pharmaceuticals, Inc. |
Perampanel |
D08964
|
|
Famotidine powder, for suspension 40 mg/5mL (ANDA)
|
RISING PHARMA HOLDINGS, INC. |
Famotidine |
D00318
|
DELFLEX solution 1.5 g00mL (NDA)
DELFLEX solution 2.5 g00mL (NDA)
DELFLEX solution 4.25 g00mL (NDA)
|
Fresenius Medical Care Renal Therapies Group, LLC |
Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride |
|
Lisdexamfetamine dimesylate capsule 70 mg (ANDA)
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)
|
Teva Pharmaceuticals, Inc. |
Lisdexamfetamine dimesylate |
D04747
|
|
Olanzapine tablet, film coated 2.5 mg (ANDA)
|
REMEDYREPACK INC. |
Olanzapine |
D00454
|
|
Carvedilol tablet, film coated 25 mg (ANDA)
|
Bryant Ranch Prepack |
Carvedilol |
D00255
|
|
ANASTROZOLE tablet 1 mg (ANDA)
|
Breckenridge Pharmaceutical, Inc. |
ANASTROZOLE |
D00960
|
Nortriptyline Hydrochloride capsule 25 mg (ANDA)
Nortriptyline Hydrochloride capsule 75 mg (ANDA)
Nortriptyline Hydrochloride capsule 50 mg (ANDA)
Nortriptyline Hydrochloride capsule 10 mg (ANDA)
|
Bryant Ranch Prepack |
Nortriptyline Hydrochloride |
D00816
|
|
MELOXICAM tablet 15 mg (ANDA)
|
REMEDYREPACK INC. |
meloxicam |
D00969
|
Depo-Testosterone injection, solution 100 mg/mL (ANDA)
Depo-Testosterone injection, solution 200 mg/mL (ANDA)
|
Pharmacia & Upjohn Company LLC |
testosterone cypionate |
D00957
|
|
GABAPENTIN suspension 250 mg/5mL (NDA AUTHORIZED GENERIC)
|
Mylan Pharmaceuticals Inc. |
gabapentin |
D00332
|
|
Simvastatin tablet, film coated 20 mg (ANDA)
|
REMEDYREPACK INC. |
Simvastatin |
D00434
|
Risperidone tablet, orally disintegrating .25 mg (ANDA)
Risperidone tablet, orally disintegrating .5 mg (ANDA)
Risperidone tablet, orally disintegrating 1 mg (ANDA)
Risperidone tablet, orally disintegrating 2 mg (ANDA)
Risperidone tablet, orally disintegrating 3 mg (ANDA)
Risperidone tablet, orally disintegrating 4 mg (ANDA)
|
Par Health USA, LLC |
Risperidone |
D00426
|
|
Argatroban injection 250 mg/2.5mL (ANDA)
|
Par Health USA, LLC |
Argatroban |
D00181
|
Cephalexin capsule 250 mg (ANDA)
Cephalexin capsule 333 mg (ANDA)
Cephalexin capsule 500 mg (ANDA)
Cephalexin capsule 750 mg (ANDA)
|
HAWAII REPACK, INC. |
Cephalexin |
D00906
|
LAMICTAL ODT tablet, orally disintegrating 25 mg (NDA)
LAMICTAL ODT tablet, orally disintegrating 50 mg (NDA)
LAMICTAL ODT tablet, orally disintegrating 100 mg (NDA)
LAMICTAL ODT tablet, orally disintegrating 200 mg (NDA)
LAMICTAL ODT kit (NDA)
LAMICTAL tablet, for suspension 5 mg (NDA)
LAMICTAL tablet, for suspension 25 mg (NDA)
LAMICTAL kit (NDA)
LAMICTAL tablet 25 mg (NDA)
LAMICTAL tablet 100 mg (NDA)
LAMICTAL tablet 150 mg (NDA)
LAMICTAL tablet 200 mg (NDA)
LAMICTAL tablet, for suspension 2 mg (NDA)
|
GlaxoSmithKline LLC |
lamotrigine |
D00354
|
|
Sorafenib tablet, film coated 200 mg (ANDA)
|
Teva Pharmaceuticals, Inc. |
Sorafenib |
D06272
|
Metformin Hydrochloride tablet, extended release 500 mg (ANDA)
Metformin Hydrochloride tablet, extended release 750 mg (ANDA)
|
Amneal Pharmaceuticals LLC |
Metformin Hydrochloride |
D00944
|
|
TRYVIO tablet, film coated 12.5 mg (NDA)
|
Idorsia Pharmaceuticals Ltd |
Aprocitentan |
D11441
|
Esomeprazole Magnesium capsule, delayed release pellets 20 mg (ANDA)
Esomeprazole Magnesium capsule, delayed release pellets 40 mg (ANDA)
|
Mylan Pharmaceuticals Inc. |
Esomeprazole Magnesium |
D01984
|
|
Amitriptyline Hydrochloride tablet 25 mg (ANDA)
|
A-S Medication Solutions |
Amitriptyline Hydrochloride |
D00809
|
|
vancomycin hydrochloride kit (ANDA)
|
Aurobindo Pharma Limited |
vancomycin hydrochloride |
D00926
|
Phenylephrine Hydrochloride injection 10 mg/mL (NDA)
IMMPHENTIV injection 100 ug/mL (NDA)
IMMPHENTIV injectable, liposomal 100 ug/mL (NDA)
|
Hikma Pharmaceuticals USA Inc. |
Phenylephrine Hydrochloride |
D00511
|
varenicline tablet, film coated .5 mg (ANDA)
varenicline tablet, film coated 1 mg (ANDA)
Varenicline kit (ANDA)
|
Ascend Laboratories, LLC |
varenicline tartrate |
D06282
|
|
OCTREOTIDE ACETATE kit (ANDA)
|
Mylan Institutional LLC |
OCTREOTIDE ACETATE |
D06495
|