| Product |
Company |
Generic name |
KEGG DRUG |
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
|
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
|
Bupropion Hydrochloride tablet, film coated 75 mg (ANDA)
Bupropion Hydrochloride tablet, film coated 100 mg (ANDA)
|
Modavar Pharmaceuticals LLC |
Bupropion Hydrochloride |
D00817
|
|
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
|
|
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
|
|
Amiodarone Hydrochloride tablet 100 mg (ANDA)
|
NCS HealthCare of KY, LLC dba Vangard Labs |
Amiodarone Hydrochloride |
D00636
|
|
Boncresa injection, solution 60 mg/mL (BLA)
|
Amneal Pharmaceuticals LLC |
denosumab-mobz |
D03684
|
Potassium Citrate tablet, extended release 10 meq (ANDA)
Potassium Citrate tablet, extended release 15 meq (ANDA)
|
ANI Pharmaceuticals, Inc. |
Potassium Citrate |
D05578
|
|
omega-3-acid ethyl esters capsule, liquid filled 900 mg (ANDA)
|
Chartwell RX, LLC |
omega-3-acid ethyl esters |
D05255
|
|
XELPROS solution/ drops .05 mg/mL (NDA)
|
Sun Pharmaceutical Industries, Inc. |
latanoprost |
D00356
|
|
LATISSE solution/ drops .3 mg/mL (NDA)
|
Allergan, Inc. |
bimatoprost |
D02724
|
|
ADDYI tablet, film coated 100 mg (NDA)
|
Sprout Pharmaceuticals, Inc. |
flibanserin |
D02577
|
Hydrocodone Bitartrate and Acetaminophen tablet 5 mg (ANDA)
Hydrocodone Bitartrate and Acetaminophen tablet 7.5 mg (ANDA)
Hydrocodone Bitartrate and Acetaminophen tablet 10 mg (ANDA)
|
Aurolife Pharma, LLC |
Hydrocodone Bitartrate and Acetaminophen |
D00846
|
Nebivolol tablet 2.5 mg (ANDA)
Nebivolol tablet 5 mg (ANDA)
Nebivolol tablet 10 mg (ANDA)
Nebivolol tablet 20 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Nebivolol |
D06622
|
|
pimavanserin capsule 34 mg (ANDA)
|
Novadoz Pharmaceuticals LLC |
pimavanserin |
D08969
|
Etodolac capsule 300 mg (ANDA)
Etodolac capsule 200 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Etodolac |
D00315
|
Pantoprazole Sodium tablet, delayed release 20 mg (ANDA)
Pantoprazole Sodium tablet, delayed release 40 mg (ANDA)
|
Chartwell RX, LLC |
Pantoprazole Sodium |
D02593
|
|
Oxygen gas 990 mL/L (NDA)
|
Medcyl Operations Inc. |
Oxygen |
D00003
|
|
Travoprost ophthalmic solution solution/ drops .04 mg/mL (ANDA)
|
Alembic Pharmaceuticals Inc. |
Travoprost ophthalmic |
D01964
|
Candesartan cilexetil tablet 4 mg (NDA AUTHORIZED GENERIC)
Candesartan cilexetil tablet 8 mg (NDA AUTHORIZED GENERIC)
Candesartan cilexetil tablet 16 mg (NDA AUTHORIZED GENERIC)
Candesartan cilexetil tablet 32 mg (NDA AUTHORIZED GENERIC)
|
ANI Pharmaceuticals, Inc. |
Candesartan cilexetil |
D00626
|
Amoxicillin capsule 250 mg (ANDA)
Amoxicillin capsule 500 mg (ANDA)
|
Chartwell RX, LLC |
Amoxicillin |
D00229
|
|
Protonix I.V. injection, powder, for solution 40 mg0mL (NDA)
|
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
PANTOPRAZOLE SODIUM |
D02593
|
|
VIBATIV injection, powder, lyophilized, for solution 15 mg/mL (NDA)
|
Cumberland Pharmaceuticals Inc. |
telavancin hydrochloride |
D06057
|