| Product |
Company |
Generic name |
KEGG DRUG |
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
|
|
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
|
|
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
|
|
ZEVTERA injection, powder, for solution 667 mg (NDA)
|
La Jolla Pharmaceutical Company |
ceftobiprole medocaril sodium |
D08886
|
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 300 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
|
|
Air, Compressed gas 21 L00L (NDA)
|
Messer Gas Puerto Rico Inc |
Nitrogen, Oxygen |
D03043
|
|
BENZONATATE capsule 200 mg (ANDA)
|
QPharma, Inc. |
BENZONATATE |
D00242
|
|
Oxygen, Compressed U.S.P. gas 1 L/L (NDA)
|
Techgas Inc. |
Oxygen, Compressed U.S.P. |
D00003
|
Diovan tablet 40 mg (NDA)
Diovan tablet 80 mg (NDA)
Diovan tablet 160 mg (NDA)
Diovan tablet 320 mg (NDA)
|
Novartis Pharmaceuticals Corporation |
valsartan |
D00400
|
|
AMELUZ gel 100 mg/g (NDA)
|
Biofrontera Inc. |
aminolevulinic acid hydrochloride |
D02908
|
|
Bumetanide injection .25 mg/mL (ANDA)
|
GLENMARK PHARMACEUTICALS INC., USA |
Bumetanide |
D00247
|
PAROXETINE tablet, film coated 10 mg (ANDA)
PAROXETINE tablet, film coated 20 mg (ANDA)
PAROXETINE tablet, film coated 30 mg (ANDA)
PAROXETINE tablet, film coated 40 mg (ANDA)
|
Chartwell RX, LLC. |
PAROXETINE |
D02260
|
Micafungin injection, powder, lyophilized, for solution 10 mg/mL (ANDA)
Micafungin injection, powder, lyophilized, for solution 20 mg/mL (ANDA)
|
Zydus Lifesciences Limited |
Micafungin |
D02465
|
|
Diphenoxylate Hydrochloride and Atropine Sulfate tablet .025 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Diphenoxylate Hydrochloride and Atropine Sulfate |
D00301
|
Methylprednisolone Sodium Succinate injection, powder, lyophilized, for solution 40 mg/mL (ANDA)
Methylprednisolone Sodium Succinate injection, powder, lyophilized, for solution 125 mg/2mL (ANDA)
Methylprednisolone Sodium Succinate injection, powder, lyophilized, for solution 500 mg/8mL (ANDA)
Methylprednisolone Sodium Succinate injection, powder, lyophilized, for solution 1 g6mL (ANDA)
Methylprednisolone Sodium Succinate injection, powder, lyophilized, for solution 2 g/30.6mL (ANDA)
|
Tianjin Kingyork Pharmaceuticals Co., Ltd |
Methylprednisolone |
D00751
|
Olmesartan Medoxomil tablet 5 mg (ANDA)
Olmesartan Medoxomil tablet 20 mg (ANDA)
Olmesartan Medoxomil tablet 40 mg (ANDA)
|
Chartwell RX, LLC |
Olmesartan Medoxomil |
D01204
|
PREGABALIN capsules, CV capsule 25 mg (ANDA)
PREGABALIN capsules, CV capsule 50 mg (ANDA)
PREGABALIN capsules, CV capsule 75 mg (ANDA)
PREGABALIN capsules, CV capsule 100 mg (ANDA)
PREGABALIN capsules, CV capsule 150 mg (ANDA)
PREGABALIN capsules, CV capsule 200 mg (ANDA)
PREGABALIN capsules, CV capsule 225 mg (ANDA)
PREGABALIN capsules, CV capsule 300 mg (ANDA)
|
Cipla USA Inc. |
PREGABALIN capsules, CV |
D02716
|