| Product |
Company |
Generic name |
KEGG DRUG |
MUTAMYCIN injection, powder, lyophilized, for solution 5 mg0mL (ANDA)
MUTAMYCIN injection, powder, lyophilized, for solution 40 mg/80mL (ANDA)
|
Accord BioPharma Inc. |
Mitomycin |
D00208
|
|
CYSTEINE HYDROCHLORIDE injection 34.5 mg/mL (NDA)
|
Baxter Healthcare Corporation |
cysteine hydrochloride |
D02326
|
Metolazone tablet 2.5 mg (ANDA)
Metolazone tablet 5 mg (ANDA)
Metolazone tablet 10 mg (ANDA)
|
Amici Pharma, Inc |
Metolazone |
D00431
|
|
Ciprofloxacin tablet, film coated 500 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Ciprofloxacin Hydrochloride |
D02216
|
|
METFORMIN HYDROCHLORIDE EXTENDED RELEASE tablet, extended release 750 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Metformin Hydrochloride |
D00944
|
Furosemide injection 100 mg0mL (ANDA)
Furosemide injection 20 mg/2mL (ANDA)
Furosemide injection 40 mg/4mL (ANDA)
|
Amneal Pharmaceuticals LLC |
Furosemide |
D00331
|
|
doxycycline capsule 100 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
doxycycline |
D00307
|
|
Triamterene and Hydrochlorothiazide capsule 25 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Triamterene and Hydrochlorothiazide |
D10269
|
|
CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated 10 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
cyclobenzaprine hydrochloride |
D00772
|
|
CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated 5 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
cyclobenzaprine hydrochloride |
D00772
|
|
Potassium Chloride for solution 1.5 g.58g (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Potassium Chloride |
D02060
|
|
ALTUVIIIO kit (BLA)
|
Bioverativ Therapeutics Inc. |
Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl |
|
tizanidine tablet 2 mg (ANDA)
tizanidine tablet 4 mg (ANDA)
|
Apotex Corp. |
tizanidine |
D00776
|
|
Diclofenac sodium solution 20 mg/g (ANDA)
|
Alembic Pharmaceuticals Limited |
Diclofenac sodium |
D00904
|
|
Mesna injection, solution 100 mg/mL (ANDA)
|
Sagent Pharmaceuticals |
mesna |
D01459
|
lurasidone hydrochloride tablet, film coated 20 mg (ANDA)
lurasidone hydrochloride tablet, film coated 40 mg (ANDA)
lurasidone hydrochloride tablet, film coated 60 mg (ANDA)
lurasidone hydrochloride tablet, film coated 80 mg (ANDA)
lurasidone hydrochloride tablet, film coated 120 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
lurasidone hydrochloride |
D04820
|
|
VITAMIN D capsule 1.25 mg (ANDA)
|
Strides Pharma Science Limited |
ergocalciferol |
D00187
|
|
Amoxicillin and Clavulanate Potassium powder, for suspension 200 mg/5mL (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Amoxicillin and Clavulanate Potassium |
D06485
|
|
SPIRONOLACTONE tablet 25 mg (ANDA)
|
Bryant Ranch Prepack |
SPIRONOLACTONE |
D00443
|
|
Azithromycin Dihydrate tablet, film coated 500 mg (ANDA)
|
TAGI Pharma, Inc. |
Azithromycin Dihydrate |
D02134
|
SEROQUEL XR tablet, extended release 200 mg (NDA)
SEROQUEL XR tablet, extended release 300 mg (NDA)
SEROQUEL XR tablet, extended release 400 mg (NDA)
SEROQUEL XR tablet, extended release 50 mg (NDA)
SEROQUEL XR tablet, extended release 150 mg (NDA)
|
AstraZeneca Pharmaceuticals LP |
quetiapine |
D00458
|
Treprostinil injection, solution 20 mg/20mL (ANDA)
Treprostinil injection, solution 50 mg/20mL (ANDA)
Treprostinil injection, solution 100 mg/20mL (ANDA)
Treprostinil injection, solution 200 mg/20mL (ANDA)
|
Alembic Pharmaceuticals Inc. |
Treprostinil |
D06213
|
Midodrine Hydrochloride tablet 2.5 mg (ANDA)
Midodrine Hydrochloride tablet 5 mg (ANDA)
Midodrine Hydrochloride tablet 10 mg (ANDA)
|
Umasuto, LLC |
Midodrine Hydrochloride |
D01307
|
|
Clopidogrel tablet, film coated 75 mg (ANDA)
|
Legacy Pharmaceutical Packaging, LLC |
Clopidogrel Bisulfate |
D00769
|
|
Valganciclovir tablet, film coated 450 mg (ANDA)
|
Major Pharmaceuticals |
Valganciclovir |
D03256
|
|
CIPROFLOXACIN HYDROCHLORIDE solution 3 mg/mL (ANDA)
|
Advagen Pharma Limited |
CIPROFLOXACIN HYDROCHLORIDE |
D02216
|
Gabapentin tablet, coated 800 mg (ANDA)
Gabapentin tablet, coated 600 mg (ANDA)
|
Precision Dose, Inc. |
Gabapentin |
D00332
|
|
Acetaminophen injection 10 mg/mL (NDA)
|
B. Braun Medical Inc. |
Acetaminophen |
D00217
|
Esomeprazole Magnesium for delayed-release oral suspension granule, delayed release 2.5 mg (ANDA)
Esomeprazole Magnesium for delayed-release oral suspension granule, delayed release 5 mg (ANDA)
Esomeprazole Magnesium for delayed-release oral suspension granule, delayed release 20 mg (ANDA)
Esomeprazole Magnesium for delayed-release oral suspension granule, delayed release 40 mg (ANDA)
|
Torrent Pharmaceuticals Limited |
Esomeprazole Magnesium |
D01984
|
|
ETHOSUXIMIDE capsule 250 mg (ANDA)
|
Strides Pharma Science Limited |
ETHOSUXIMIDE |
D00539
|
CELECOXIB capsule 100 mg (ANDA)
CELECOXIB capsule 200 mg (ANDA)
|
Quallent Pharmaceuticals Health LLC |
CELECOXIB |
D00567
|
ENALAPRIL MALEATE tablet 5 mg (ANDA)
ENALAPRIL MALEATE tablet 10 mg (ANDA)
ENALAPRIL MALEATE tablet 20 mg (ANDA)
|
Legacy Pharmaceutical Packaging, LLC |
ENALAPRIL MALEATE |
D00621
|
|
Lincocin injection, solution 300 mg/mL (NDA)
|
Pharmacia & Upjohn Company LLC |
lincomycin hydrochloride |
D02346
|
|
Famotidine tablet, film coated 20 mg (ANDA)
|
Legacy Pharmaceutical Packaging, LLC |
Famotidine |
D00318
|
CELECOXIB capsule 50 mg (ANDA)
CELECOXIB capsule 100 mg (ANDA)
CELECOXIB capsule 200 mg (ANDA)
CELECOXIB capsule 400 mg (ANDA)
|
NorthStar RxLLC |
CELECOXIB |
D00567
|
|
Clarithromycin tablet, film coated 500 mg (ANDA)
|
Major Pharmaceuticals |
Clarithromycin |
D00276
|
CELECOXIB capsule 50 mg (ANDA)
CELECOXIB capsule 400 mg (ANDA)
CELECOXIB capsule 200 mg (ANDA)
CELECOXIB capsule 100 mg (ANDA)
|
Cipla USA Inc. |
CELECOXIB |
D00567
|
|
Teriparatide injection, solution 250 ug/mL (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Teriparatide |
D06546
|
Metoprolol Tartrate tablet 50 mg (ANDA)
Metoprolol Tartrate tablet 100 mg (ANDA)
|
Proficient Rx LP |
Metoprolol Tartrate |
D00601
|
|
leflunomide tablet 10 mg (ANDA)
|
Bryant Ranch Prepack |
leflunomide |
D00749
|