| Product |
Company |
Generic name |
KEGG DRUG |
Octreotide Acetate injection, solution 50 ug/mL (ANDA)
Octreotide Acetate injection, solution 100 ug/mL (ANDA)
Octreotide Acetate injection, solution 500 ug/mL (ANDA)
|
Meitheal Pharmaceuticals, Inc. |
Octreotide Acetate |
D06495
|
Zolpidem Tartrate tablet, coated 5 mg (ANDA)
Zolpidem Tartrate tablet, coated 10 mg (ANDA)
|
Sandoz Inc |
Zolpidem Tartrate |
D00706
|
|
Bupropion Hydrochloride SR tablet, film coated, extended release 150 mg (ANDA)
|
Northwind Pharmaceuticals, LLC |
bupropion hydrochloride |
D00817
|
|
Ergocalciferol capsule, liquid filled 1.25 mg (ANDA)
|
Bryant Ranch Prepack |
Ergocalciferol |
D00187
|
|
Imiquimod cream 12.5 mg/.25g (ANDA)
|
Padagis Israel Pharmaceuticals Ltd |
Imiquimod |
D02500
|
Methylphenidate Hydrochloride tablet 5 mg (ANDA)
Methylphenidate Hydrochloride tablet 10 mg (ANDA)
Methylphenidate Hydrochloride tablet 20 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Methylphenidate Hydrochloride |
D01296
|
|
Chlorhexidine Gluconate rinse 1.2 mg/mL (ANDA)
|
Preferred Pharmaceuticals, Inc. |
Chlorhexidine Gluconate |
D00858
|
|
Atorvastatin Calcium tablet, film coated 10 mg (ANDA)
|
Bryant Ranch Prepack |
Atorvastatin Calcium |
D02258
|
|
Protopam Chloride injection, powder, lyophilized, for solution 1 g/20mL (NDA)
|
Baxter Healthcare Corporation |
pralidoxime chloride |
D00469
|
|
Phentermine Hydrochloride tablet 37.5 mg (ANDA)
|
Calvin Scott & Co., Inc. |
PHENTERMINE HYDROCHLORIDE |
D05459
|
|
Ibuprofen tablet, film coated 800 mg (ANDA)
|
Northwind Pharmaceuticals, LLC |
Ibuprofen |
D00126
|
|
Fosaprepitant injection, powder, lyophilized, for solution 150 mg/5mL (ANDA)
|
Baxter Healthcare Corporation |
Fosaprepitant Dimeglumine |
D06597
|
|
rifampin capsule 300 mg (ANDA)
|
Major Pharmaceuticals |
rifampin |
D00211
|
|
Abacavir tablet, film coated 300 mg (ANDA)
|
Major Pharmaceuticals |
Abacavir |
D00891
|
|
DALVANCE injection, powder, for solution 500 mg/25mL (NDA)
|
Allergan, Inc. |
Dalbavancin |
D13218
|
|
BYFAVO injection, powder, lyophilized, for solution 2.5 mg/mL (NDA)
|
Acacia Pharma, Ltd. |
remimazolam besylate |
D10194
|
|
Protonix I.V. injection, powder, for solution 40 mg0mL (NDA)
|
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
PANTOPRAZOLE SODIUM |
D02593
|
TAGRISSO tablet, film coated 40 mg (NDA)
TAGRISSO tablet, film coated 80 mg (NDA)
|
AstraZeneca Pharmaceuticals LP |
osimertinib |
D10766
|
Pantoprazole Sodium tablet, delayed release 40 mg (ANDA)
Pantoprazole Sodium tablet, delayed release 20 mg (ANDA)
|
Cardinal Health 107, LLC |
Pantoprazole Sodium |
D02593
|
Meropenem injection, powder, for solution 500 mg (ANDA)
Meropenem injection, powder, for solution 1 g (ANDA)
|
WG Critical Care, LLC |
Meropenem |
D02222
|
Nebivolol tablet 2.5 mg (ANDA)
Nebivolol tablet 5 mg (ANDA)
Nebivolol tablet 10 mg (ANDA)
Nebivolol tablet 20 mg (ANDA)
|
Aurobindo Pharma Limited |
Nebivolol |
D06622
|
|
Phentermine hydrochloride capsule 37.5 mg (ANDA)
|
Bryant Ranch Prepack |
phentermine hydrochloride |
D05459
|
Meropenem injection, powder, for solution 500 mg (ANDA)
Meropenem injection, powder, for solution 1 g (ANDA)
|
WG Critical Care, LLC |
Meropenem |
D02222
|
|
Olmesartan Medoxomil and Hydrochlorothiazide tablet 12.5 mg (ANDA)
|
Bryant Ranch Prepack |
Olmesartan Medoxomil and Hydrochlorothiazide |
D10284
|
|
CARMUSTINE kit (ANDA)
|
Sandoz Inc. |
CARMUSTINE |
D00254
|
SINEMET tablet 10 mg (NDA)
SINEMET tablet 25 mg (NDA)
|
Organon LLC |
carbidopa and levodopa |
D00253
|
Zolpidem tartrate tablet, extended release 6.25 mg (ANDA)
Zolpidem tartrate tablet, extended release 12.5 mg (ANDA)
|
Sandoz Inc |
Zolpidem tartrate |
D00706
|
|
Abiraterone Acetate tablet 250 mg (ANDA)
|
American Health Packaging |
Abiraterone |
D09701
|
Eligard injection, suspension, extended release 22.5 mg/.375mL (NDA)
Eligard injection, suspension, extended release 30 mg/.5mL (NDA)
Eligard injection, suspension, extended release 7.5 mg/.25mL (NDA)
Eligard injection, suspension, extended release 45 mg/.375mL (NDA)
|
TOLMAR Inc. |
Leuprolide acetate |
D00989
|
|
Ertapenem injection, powder, lyophilized, for solution 1 g (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
ertapenem sodium |
D04049
|
|
PRAVASTATIN SODIUM tablet 80 mg (ANDA)
|
Bryant Ranch Prepack |
PRAVASTATIN SODIUM |
D00893
|
|
sevelamer hydrochloride tablet, film coated 800 mg (ANDA)
|
Cardinal Health 107, LLC |
sevelamer hydrochloride |
D01983
|
Famotidine tablet, coated 20 mg (ANDA)
Famotidine tablet, coated 40 mg (ANDA)
|
Proficient Rx LP |
Famotidine |
D00318
|
|
Myalept injection, powder, lyophilized, for solution 11.3 mg/2.2mL (BLA)
|
Amryt Pharmaceuticals Designated Activity Company |
metreleptin |
D05014
|
|
epinephrine injection 1 mg/mL (ANDA)
|
GLENMARK PHARMACEUTICALS INC., USA |
epinephrine |
D00095
|
Cyclophosphamide injection, solution, concentrate 500 mg/5mL (NDA)
Cyclophosphamide injection, solution, concentrate 1000 mg0mL (NDA)
Cyclophosphamide injection, solution, concentrate 2000 mg/20mL (NDA)
|
Sandoz Inc |
Cyclophosphamide |
D00287
|
|
Oxybutynin Chloride solution 5 mg/5mL (ANDA)
|
Chartwell RX, LLC |
Oxybutynin Chloride |
D00722
|
|
Bupropion Hydrochloride XL tablet, film coated, extended release 150 mg (ANDA)
|
Asclemed USA, Inc. |
Bupropion Hydrochloride |
D00817
|
|
Rosyrah kit (ANDA)
|
Xiromed, LLC |
levonorgestrel and ethinyl estradiol and ethinyl estradiol |
D04482
|
|
BONJESTA tablet, extended release 20 mg (NDA)
|
Duchesnay USA, Inc. |
doxylamine succinate and pyridoxine hydrochloride |
D10357
|