| Product |
Company |
Generic name |
KEGG DRUG |
|
Erythromycin ointment 5 mg/g (ANDA)
|
Redpharm Drug |
Erythromycin |
D00140
|
|
Moxifloxacin solution/ drops 5 mg/mL (ANDA)
|
Redpharm Drug |
Moxifloxacin |
D00874
|
|
MYTESI tablet, coated 125 mg (NDA)
|
Napo Pharmaceuticals, Inc. |
Crofelemer |
D03605
|
Irbesartan and Hydrochlorothiazide tablet, film coated 12.5 mg (ANDA)
Irbesartan and Hydrochlorothiazide tablet, film coated 25 mg (ANDA)
|
Aurobindo Pharma Limited |
Irbesartan and Hydrochlorothiazide |
D10249
|
|
Corphena solution 2 mg/5mL (ANDA)
|
BluCrest Pharmaceuticals LLC |
Dexchlorpheniramine Maleate |
D00668
|
|
Ramipril capsule 2.5 mg (ANDA)
|
A-S Medication Solutions |
Ramipril |
D00421
|
Lithium Carbonate capsule 150 mg (ANDA)
Lithium Carbonate capsule 300 mg (ANDA)
Lithium Carbonate capsule 600 mg (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
Lithium Carbonate |
D00801
|
Lunsumio Velo injection 5 mg/.5mL (BLA)
Lunsumio Velo injection 45 mg/mL (BLA)
|
Genentech, Inc. |
Mosunetuzumab |
D11463
|
|
Cladribine injection, solution 1 mg/mL (ANDA)
|
Hisun Pharmaceuticals USA, Inc. |
Cladribine |
D01370
|
|
TADLIQ suspension 20 mg/5mL (NDA)
|
CMP Pharma, Inc. |
Tadalafil |
D02008
|
Pemetrexed injection, solution 100 mg/4mL (NDA)
Pemetrexed injection, solution 500 mg/20mL (NDA)
Pemetrexed injection, solution 1000 mg/40mL (NDA)
|
Sandoz Inc. |
Pemetrexed disodium |
D10596
|
|
UPLIZNA injection 10 mg/mL (BLA)
|
Horizon Therapeutics USA, Inc. |
Inebilizumab |
D11757
|
|
MoviPrep kit (NDA)
|
Salix Pharmaceuticals, Inc. |
POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE |
D11552
|
Spironolactone tablet 25 mg (ANDA)
Spironolactone tablet 50 mg (ANDA)
Spironolactone tablet 100 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC |
Spironolactone |
D00443
|
|
Oriahnn kit (NDA)
|
AbbVie Inc. |
Elagolix and Estradiol and Norethisterone |
D12137
|
|
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet, film coated 325 mg (ANDA)
|
Micro Labs Limited |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN |
D09999
|
Bosentan tablet, film coated 62.5 mg (ANDA)
Bosentan tablet, film coated 125 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Bosentan |
D01227
|
|
CaroSpir suspension 25 mg/5mL (NDA)
|
CMP Pharma, Inc. |
CaroSpir |
D00443
|
|
Teriparatide injection 250 ug/mL (ANDA)
|
Amphastar Pharmaceuticals, Inc. |
Teriparatide |
D06078
|
|
Sodium Fluoride F 18 injection 200 mCi/mL (ANDA)
|
Precision Nuclear LLC |
SODIUM FLUORIDE F-18 |
D05860
|
|
prednisone tablet 20 mg (ANDA)
|
A-S Medication Solutions |
prednisone |
D00473
|
duloxetine capsule, delayed release 20 mg (ANDA)
duloxetine capsule, delayed release 30 mg (ANDA)
duloxetine capsule, delayed release 60 mg (ANDA)
|
Qingdao BAHEAL Pharmaceutical Co., Ltd. |
Duloxetine |
D01179
|
|
DICLOFENAC POTASSIUM powder, for solution 50 mg (ANDA)
|
Nivagen Pharmaceuticals, Inc. |
Diclofenac potassium |
D00903
|
|
Arformoterol tartrate solution 15 ug/2mL (ANDA)
|
Alembic Pharmaceuticals Inc. |
Arformoterol tartrate |
D02981
|
NITYR tablet 2 mg (NDA)
NITYR tablet 10 mg (NDA)
NITYR tablet 5 mg (NDA)
|
Cycle Pharmaceuticals Ltd. |
Nitisinone |
D05177
|
VENXXIVA tablet, delayed release 100 mg (ANDA)
VENXXIVA tablet, delayed release 300 mg (ANDA)
|
Cycle Pharmaceuticals Ltd. |
tiopronin |
D01430
|
|
Ketorolac Tromethamine tablet, film coated 10 mg (ANDA)
|
REMEDYREPACK INC. |
Ketorolac Tromethamine |
D00813
|
|
sorafenib tablet, film coated 200 mg (ANDA)
|
Yabao Pharmaceutical Co., Ltd. Beijing |
sorafenib |
D06272
|
Bupropion Hydrochloride tablet, film coated 75 mg (ANDA)
Bupropion Hydrochloride tablet, film coated 100 mg (ANDA)
|
Modavar Pharmaceuticals LLC |
Bupropion Hydrochloride |
D00817
|
VOQUEZNA DUAL PAK kit (NDA)
VOQUEZNA TRIPLE PAK kit (NDA)
|
Phathom Pharmaceuticals Inc. |
vonoprazan fumarate and amoxicillin |
D12756
|
VOQUEZNA tablet 13.36 mg (NDA)
VOQUEZNA tablet 26.72 mg (NDA)
|
Phathom Pharmaceuticals Inc. |
vonoprazan fumarate |
D10466
|
|
THALLOUS CHLORIDE Tl 201 injection, solution 1 mCi/mL (NDA)
|
Curium US LLC |
thallous chloride, Tl 201 |
D02402
|
Metformin Hydrochloride tablet, film coated 500 mg (ANDA)
Metformin Hydrochloride tablet, film coated 850 mg (ANDA)
Metformin Hydrochloride tablet, film coated 1000 mg (ANDA)
Metformin Hydrochloride tablet, extended release 500 mg (ANDA)
Metformin Hydrochloride tablet, extended release 750 mg (ANDA)
|
Ascend Laboratories, LLC |
Metformin Hydrochloride |
D00944
|
Galantamine tablet, film coated 4 mg (ANDA)
Galantamine tablet, film coated 8 mg (ANDA)
Galantamine tablet, film coated 12 mg (ANDA)
|
Upsher-Smith Laboratories, LLC |
galantamine |
D02173
|
|
Omeprazole capsule, delayed release 10 mg (ANDA)
|
Chartwell RX, LLC |
Omeprazole |
D00455
|
|
Pregabalin solution 20 mg/mL (ANDA)
|
Ascend Laboratories, LLC |
Pregabalin |
D02716
|
|
Amoxicillin powder, for suspension 400 mg/5mL (ANDA)
|
Chartwell RX, LLC |
Amoxicillin |
D00229
|
Venlafaxine tablet, extended release 37.5 mg (ANDA)
Venlafaxine tablet, extended release 75 mg (ANDA)
Venlafaxine tablet, extended release 150 mg (ANDA)
Venlafaxine tablet, extended release 225 mg (ANDA)
|
Ajanta Pharma USA Inc. |
Venlafaxine |
D00821
|
|
Naproxen tablet 500 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Naproxen |
D00118
|
MOVANTIK tablet, film coated 12.5 mg (NDA)
MOVANTIK tablet, film coated 25 mg (NDA)
|
Valinor Pharma, LLC |
naloxegol oxalate |
D10375
|