| Product |
Company |
Generic name |
KEGG DRUG |
|
CROMOLYN SODIUM solution, concentrate 100 mg/5mL (ANDA)
|
Micro Labs Limited |
Cromolyn sodium |
D00526
|
|
TADALAFIL tablet 20 mg (ANDA)
|
Solco Healthcare US, LLC |
tadalafil |
D02008
|
Folotyn injection 20 mg/mL (NDA)
Folotyn injection 40 mg/2mL (NDA)
|
Acrotech Biopharma Inc |
pralatrexate |
D05589
|
DIMETHYL FUMARATE capsule, delayed release 120 mg (ANDA)
DIMETHYL FUMARATE capsule, delayed release 240 mg (ANDA)
|
Solco Healthcare US, LLC |
dimethyl fumarate |
D03846
|
|
Cromolyn Sodium inhalant 20 mg/2mL (ANDA)
|
Micro Labs Limited |
Cromolyn Sodium |
D00526
|
|
Levothyroxine sodium tablet 50 ug (ANDA)
|
Proficient Rx LP |
Levothyroxine sodium |
D01010
|
Clobazam tablet 10 mg (ANDA)
Clobazam tablet 20 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Clobazam |
D01253
|
Fluoxetine capsule 10 mg (ANDA)
Fluoxetine capsule 20 mg (ANDA)
Fluoxetine capsule 40 mg (ANDA)
|
TIME CAP LABORATORIES, INC. |
Fluoxetine Hydrochloride |
D00823
|
Nalbuphine hydrochloride injection 10 mg/mL (ANDA)
Nalbuphine hydrochloride injection 20 mg/mL (ANDA)
|
Somerset Therapeutics, LLC |
Nalbuphine hydrochloride |
D00843
|
|
Tizanidine tablet 4 mg (ANDA)
|
Bryant Ranch Prepack |
Tizanidine |
D00776
|
|
Oxaliplatin injection, solution, concentrate 5 mg/mL (ANDA)
|
Hospira, Inc. |
OXALIPLATIN |
D01790
|
Demeclocycline Hydrochloride tablet 150 mg (ANDA)
Demeclocycline Hydrochloride tablet 300 mg (ANDA)
|
American Health Packaging |
Demeclocycline |
D00290
|
|
Dorzolamide Hydrochloride and Timolol Maleate ophthalmic Solution solution/ drops 22.3 mg/mL (ANDA)
|
Micro Labs Limited |
Dorzolamide Hydrochloride and Timolol Maleate |
D08493
|
|
Penicillamine capsule 250 mg (ANDA)
|
Endo USA, Inc. |
penicillamine |
D00496
|
|
Citalopram Hydrobromide tablet 40 mg (ANDA)
|
A-S Medication Solutions |
Citalopram Hydrobromide |
D00822
|
Propranolol Hydrochloride tablet 10 mg (ANDA)
Propranolol Hydrochloride tablet 20 mg (ANDA)
Propranolol Hydrochloride tablet 40 mg (ANDA)
Propranolol Hydrochloride tablet 60 mg (ANDA)
Propranolol Hydrochloride tablet 80 mg (ANDA)
|
Endo USA, Inc. |
propranolol hydrochloride |
D00483
|
|
PRAZIQUANTEL tablet, film coated 600 mg (ANDA)
|
Endo USA, Inc. |
PRAZIQUANTEL |
D00471
|
|
CHLORPROMAZINE HCI injection 25 mg/mL (ANDA)
|
Dr. Reddy's Laboratories Inc., |
CHLORPROMAZINE HCI |
D00789
|
Glycopyrrolate tablet 1 mg (ANDA)
Glycopyrrolate tablet 2 mg (ANDA)
|
Endo USA, Inc. |
glycopyrrolate |
D00540
|
|
Cefazolin Sodium injection, powder, for solution 1 g (ANDA)
|
Direct_rx |
Cefazolin Sodium |
D00905
|
|
Famotidine tablet, film coated 20 mg (ANDA)
|
American Health Packaging |
Famotidine |
D00318
|
Estradiol tablet .5 mg (ANDA)
Estradiol tablet 1 mg (ANDA)
Estradiol tablet 2 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Estradiol |
D00105
|
|
Hydrocortisone sodium succinate injection 100 mg/2mL (ANDA)
|
Cipla USA Inc. |
Hydrocortisone sodium succinate |
D00978
|
Hydroxyzine Hydrochloride tablet, film coated 10 mg (ANDA)
Hydroxyzine Hydrochloride tablet, film coated 25 mg (ANDA)
|
American Health Packaging |
Hydroxyzine Hydrochloride |
D00672
|
Clorazepate Dipotassium tablet 3.75 mg (ANDA)
Clorazepate Dipotassium tablet 7.5 mg (ANDA)
Clorazepate Dipotassium tablet 15 mg (ANDA)
|
Taro Pharmaceuticals U.S.A., Inc. |
Clorazepate Dipotassium |
D00694
|
|
clobetasol propionate shampoo .05 g00mL (ANDA)
|
Padagis Israel Pharmaceuticals Ltd |
Clobetasol Propionate |
D01272
|
Methimazole tablet 10 mg (ANDA)
Methimazole tablet 5 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Methimazole |
D00401
|
|
Metoprolol succinate tablet, extended release 100 mg (ANDA)
|
NCS HealthCare of KY, LLC dba Vangard Labs |
Metoprolol succinate |
D00635
|
Tolvaptan tablet 15 mg (ANDA)
Tolvaptan tablet 30 mg (ANDA)
|
Endo USA, Inc. |
Tolvaptan |
D01213
|
|
sulfADIAZINE tablet 500 mg (ANDA)
|
Chartwell RX, LLC |
sulfADIAZINE |
D00587
|
|
Bortezomib injection 3.5 mg.4mL (NDA)
|
Shilpa Medicare Limited |
Bortezomib |
D03150
|
Isosorbide Dinitrate tablet 5 mg (ANDA)
Isosorbide Dinitrate tablet 10 mg (ANDA)
Isosorbide Dinitrate tablet 20 mg (ANDA)
Isosorbide Dinitrate tablet 30 mg (ANDA)
|
Endo USA, Inc. |
isosorbide dinitrate |
D00516
|
Pimozide tablet 1 mg (ANDA)
Pimozide tablet 2 mg (ANDA)
|
Endo USA, Inc. |
Pimozide |
D00560
|
Buspirone Hydrochloride tablet 15 mg (ANDA)
Buspirone Hydrochloride tablet 5 mg (ANDA)
Buspirone Hydrochloride tablet 10 mg (ANDA)
|
NCS HealthCare of KY, LLC dba Vangard Labs |
Buspirone Hydrochloride |
D00702
|
|
penicillamine tablet, film coated 250 mg (ANDA)
|
Endo USA, Inc. |
penicillamine |
D00496
|
|
Doxorubicin Hydrochloride injection, solution 2 mg/mL (ANDA)
|
Gland Pharma Limited |
Doxorubicin Hydrochloride |
D01275
|
|
Phytonadione tablet 5 mg (ANDA)
|
American Health Packaging |
Phytonadione |
D00148
|
Ampicillin and Sulbactam injection, powder, for solution 1 g.5g (ANDA)
Ampicillin and Sulbactam injection, powder, for solution 2 g/3g (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Ampicillin and Sulbactam |
D02065
|
|
Estarylla kit (ANDA)
|
Bryant Ranch Prepack |
Norgestimate and ethinyl estradiol |
D10590
|
Allopurinol tablet 100 mg (ANDA)
Allopurinol tablet 300 mg (ANDA)
Allopurinol tablet 200 mg (ANDA)
|
Leading Pharma, LLC |
Allopurinol |
D00224
|