| Product |
Company |
Generic name |
KEGG DRUG |
|
Promethazine Hydrochloride and Dextromethorphan Hydrobromide solution 15 mg/5mL (ANDA)
|
Bryant Ranch Prepack |
Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
D11854
|
bupropion tablet, extended release 300 mg (ANDA)
bupropion tablet, extended release 150 mg (ANDA)
|
Zydus Lifesciences Limited |
bupropion |
D00817
|
|
YCANTH solution 3.2 mg/.45mL (NDA)
|
Verrica Pharmaceuticals Inc. |
Cantharidin |
D11745
|
|
SIROLIMUS solution 1 mg/mL (ANDA)
|
Camber Pharmaceuticals, Inc. |
Sirolimus |
D00753
|
Azathioprine tablet 25 mg (ANDA)
Azathioprine tablet 75 mg (ANDA)
Azathioprine tablet 100 mg (ANDA)
|
Zydus Lifesciences Limited |
Azathioprine |
D00238
|
|
Bromocriptine mesylate capsule 5 mg (ANDA)
|
Zydus Lifesciences Limited |
Bromocriptine mesylate |
D00780
|
Benzonatate capsule 100 mg (ANDA)
Benzonatate capsule 200 mg (ANDA)
|
Zydus Lifesciences Limited |
Benzonatate |
D00242
|
|
Voraxaze injection, powder, for solution 1000 [USP'U] (BLA)
|
BTG International Inc. |
glucarpidase |
D10260
|
|
Betamethasone dipropionate cream .5 mg/g (ANDA)
|
Zydus Lifesciences Limited |
Betamethasone dipropionate |
D01637
|
|
Clindamycin Phosphate and Benzoyl Peroxide gel 50 mg/g (ANDA)
|
Zydus Lifesciences Limited |
Clindamycin Phosphate and Benzoyl Peroxide |
D10602
|
Colchicine tablet .6 mg (ANDA)
Colchicine tablet .3 mg (ANDA)
|
Zydus Lifesciences Limited |
Colchicine |
|
|
Azathioprine tablet 50 mg (ANDA)
|
Zydus Lifesciences Limited |
Azathioprine |
D00238
|
Rosuvastatin tablet 5 mg (ANDA)
Rosuvastatin tablet 10 mg (ANDA)
Rosuvastatin tablet 20 mg (ANDA)
Rosuvastatin tablet 40 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Rosuvastatin |
D01915
|
CLOMIPRAMINE HYDROCHLORIDE capsule 25 mg (NDA)
CLOMIPRAMINE HYDROCHLORIDE capsule 50 mg (NDA)
CLOMIPRAMINE HYDROCHLORIDE capsule 75 mg (NDA)
|
SpecGx LLC |
clomipramine hydrochloride |
D00811
|
|
Moxifloxacin Hydrochloride solution/ drops 5 mg/mL (ANDA)
|
Somerset Therapeutics, LLC |
Moxifloxacin Hydrochloride |
D00874
|
Gemcitabine injection, solution 200 mg/5.26mL (ANDA)
Gemcitabine injection, solution 1 g/26.3mL (ANDA)
Gemcitabine injection, solution 2 g/52.6mL (ANDA)
|
Mylan Institutional LLC |
GEMCITABINE HYDROCHLORIDE |
D01155
|
|
Glipizide tablet 5 mg (ANDA)
|
Bryant Ranch Prepack |
Glipizide |
D00335
|
Ambrisentan tablet, film coated 5 mg (ANDA)
Ambrisentan tablet, film coated 10 mg (ANDA)
|
Zydus Lifesciences Limited |
Ambrisentan |
D07077
|
|
Indomethacin capsule 25 mg (ANDA)
|
A-S Medication Solutions |
Indomethacin |
D00141
|
|
prochlorperazine edisylate injection 5 mg/mL (ANDA)
|
Mylan Institutional LLC |
prochlorperazine edisylate |
D02609
|
Cyclobenzaprine Hydrochloride tablet, film coated 5 mg (ANDA)
Cyclobenzaprine Hydrochloride tablet, film coated 7.5 mg (ANDA)
Cyclobenzaprine Hydrochloride tablet, film coated 10 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Cyclobenzaprine Hydrochloride |
D00772
|
|
Nifedipine tablet, extended release 30 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Nifedipine |
D00437
|
|
Diclofenac Sodium solution 20 mg/g (ANDA)
|
Asclemed USA, Inc |
Diclofenac Sodium |
D00904
|
ELIQUIS tablet, film coated 5 mg (NDA)
ELIQUIS tablet, film coated 2.5 mg (NDA)
|
A-S Medication Solutions |
apixaban |
D03213
|
BUPROPION HYDROCHLORIDE tablet, extended release 150 mg (ANDA)
BUPROPION HYDROCHLORIDE tablet, extended release 300 mg (ANDA)
|
Accord Healthcare Inc. |
BUPROPION HYDROCHLORIDE |
D00817
|
|
Fluphenazine Decanoate injection, solution 25 mg/mL (ANDA)
|
Mylan Institutional LLC |
FLUPHENAZINE DECANOATE |
D00793
|
|
budesonide capsule 3 mg (NDA)
|
Padagis US LLC |
budesonide |
D00246
|
|
Oxybutynin Chloride tablet 5 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Oxybutynin Chloride |
D00722
|
|
Methocarbamol tablet 750 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
methocarbamol |
D00402
|
Amiodarone hydrochloride tablet 200 mg (ANDA)
Amiodarone hydrochloride tablet 100 mg (ANDA)
Amiodarone hydrochloride tablet 400 mg (ANDA)
|
Zydus Lifesciences Limited |
Amiodarone hydrochloride |
D00636
|
Teflaro powder, for solution 400 mg/20mL (NDA)
Teflaro powder, for solution 600 mg/20mL (NDA)
|
Allergan, Inc. |
ceftaroline fosamil |
D08884
|
|
Clotrimazole and Betamethasone Dipropionate cream .5 mg/g (ANDA)
|
A-S Medication Solutions |
Clotrimazole and Betamethasone Dipropionate |
D10300
|
|
Lacosamide solution 10 mg/mL (ANDA)
|
Glenmark Pharmaceuticals Limited |
Lacosamide |
D07299
|
|
IVERMECTIN tablet 3 mg (ANDA)
|
DR. REDDY'S LABORATORIES, INC. |
ivermectin |
D00804
|
Escitalopram Oxalate tablet, film coated 5 mg (ANDA)
Escitalopram Oxalate tablet, film coated 10 mg (ANDA)
Escitalopram Oxalate tablet, film coated 20 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC |
Escitalopram Oxalate |
D02567
|
|
posaconazole injection, solution 18 mg/mL (ANDA)
|
Gland Pharma Limited |
posaconazole |
D02555
|
deferasirox tablet, for suspension 125 mg (ANDA)
deferasirox tablet, for suspension 250 mg (ANDA)
deferasirox tablet, for suspension 500 mg (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
deferasirox |
D03669
|
|
Clemastine Fumarate syrup .67 mg/5mL (ANDA)
|
Genus Lifesciences |
Clemastine Fumarate |
D00666
|
|
Neomycin and Polymyxin B Sulfates and Hydrocortisone suspension/ drops 10 mg/mL (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone |
D11855
|
|
Oxytocin injection, solution 10 [USP'U]/mL (NDA)
|
Fresenius Kabi USA, LLC |
OXYTOCIN |
D00089
|