| Product |
Company |
Generic name |
KEGG DRUG |
TicoVac injection 2.4 ug/.5mL (BLA)
TicoVac injection 1.2 ug/.25mL (BLA)
|
Pfizer Laboratories Div Pfizer Inc |
Tick-Borne Encephalitis Vaccine |
D12206
|
|
AVSOLA injection, powder, lyophilized, for solution 100 mg0mL (BLA)
|
Amgen, Inc |
infliximab-axxq |
D02598
|
Indapamide tablet, film coated 1.25 mg (ANDA)
Indapamide tablet, film coated 2.5 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Indapamide |
D00345
|
Doxepin Hydrochloride capsule 10 mg (ANDA)
Doxepin Hydrochloride capsule 25 mg (ANDA)
Doxepin Hydrochloride capsule 50 mg (ANDA)
Doxepin Hydrochloride capsule 100 mg (ANDA)
|
Major Pharmaceuticals |
Doxepin Hydrochloride |
D00814
|
|
Methocarbamol Tablets, USP, 500 mg tablet, film coated 500 mg (ANDA)
|
Bryant Ranch Prepack |
Methocarbamol |
D00402
|
|
clonidine hydrochloride tablet .1 mg (ANDA)
|
REMEDYREPACK INC. |
clonidine hydrochloride |
D00604
|
Carvedilol tablet, film coated 12.5 mg (ANDA)
Carvedilol tablet, film coated 25 mg (ANDA)
Carvedilol tablet, film coated 3.125 mg (ANDA)
Carvedilol tablet, film coated 6.25 mg (ANDA)
|
BluePoint Laboratories |
Carvedilol |
D00255
|
|
Bexarotene capsule, liquid filled 75 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Bexarotene |
D03106
|
|
Pregabalin capsule 100 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Pregabalin |
D02716
|
|
Triamterene and Hydrochlorothiazide tablet 25 mg (ANDA)
|
Bryant Ranch Prepack |
Triamterene and Hydrochlorothiazide |
D10269
|
ROPIVACAINE HYDROCHLORIDE injection, solution 2 mg/mL (ANDA)
ROPIVACAINE HYDROCHLORIDE injection, solution 5 mg/mL (ANDA)
ROPIVACAINE HYDROCHLORIDE injection, solution 10 mg/mL (ANDA)
|
Anthea Pharma Private Limited |
ROPIVACAINE HYDROCHLORIDE |
D04048
|
|
Pregabalin capsule 150 mg (ANDA)
|
REMEDYREPACK INC. |
Pregabalin |
D02716
|
Otezla tablet, film coated 30 mg (NDA)
Otezla kit (NDA)
Otezla tablet, film coated 20 mg (NDA)
Otezla tablet, film coated 75 mg (NDA)
|
Amgen, Inc |
apremilast |
D08860
|
MAXALT tablet 10 mg (NDA)
MAXALT-MLT tablet, orally disintegrating 10 mg (NDA)
|
Organon LLC |
rizatriptan benzoate |
D00675
|
Creon capsule, delayed release pellets 30000 [USP'U] (BLA)
Creon capsule, delayed release pellets 60000 [USP'U] (BLA)
Creon capsule, delayed release pellets 120000 [USP'U] (BLA)
Creon capsule, delayed release 15000 [USP'U] (BLA)
Creon capsule, delayed release pellets 180000 [USP'U] (BLA)
|
AbbVie Inc. |
Pancrelipase |
D05349
|
|
Jemperli injection 50 mg/mL (BLA)
|
GlaxoSmithKline LLC |
dostarlimab |
D11366
|
|
Pregabalin capsule 75 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
PREGABALIN |
D02716
|
|
Carbinoxamine Maleate Extended-Release Oral Suspension suspension, extended release 4 mg/5mL (NDA AUTHORIZED GENERIC)
|
Neos Therapeutics, LP |
Carbinoxamine Maleate |
D01336
|
|
bivalirudin injection, powder, lyophilized, for solution 250 mg (NDA AUTHORIZED GENERIC)
|
Civica, Inc. |
bivalirudin |
D11280
|
IRBESARTAN tablet 75 mg (ANDA)
IRBESARTAN tablet 150 mg (ANDA)
IRBESARTAN tablet 300 mg (ANDA)
|
AvKARE |
IRBESARTAN |
D00523
|
isoniazid tablet 100 mg (ANDA)
isoniazid tablet 300 mg (ANDA)
|
Marlex Pharmaceuticals, Inc. |
isoniazid |
D00346
|
|
INFLECTRA injection, powder, lyophilized, for solution 100 mg0mL (BLA)
|
Pfizer Laboratories Div Pfizer Inc |
infliximab-dyyb |
D02598
|
|
GAVILYTE G TM powder, for solution 236 g/274.31g (ANDA)
|
Lupin Pharmaceuticals,Inc. |
polyethylene glycol-3350 and Electrolytes |
|
Potassium Chloride for Oral Solution solution 1.5 g.58g (ANDA)
Potassium Chloride for Oral Solution solution 3 g/4.75g (ANDA)
|
Marlex Pharmaceuticals Inc |
Potassium Chloride for Oral Solution |
D02060
|
Minocycline Hydrochloride tablet, film coated, extended release 45 mg (ANDA)
Minocycline Hydrochloride tablet, film coated, extended release 65 mg (ANDA)
Minocycline Hydrochloride tablet, film coated, extended release 55 mg (ANDA)
Minocycline Hydrochloride tablet, film coated, extended release 80 mg (ANDA)
Minocycline Hydrochloride tablet, film coated, extended release 105 mg (ANDA)
Minocycline Hydrochloride tablet, film coated, extended release 115 mg (ANDA)
Minocycline Hydrochloride tablet, film coated, extended release 135 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Minocycline Hydrochloride |
D00850
|
|
Fluoxetine tablet 60 mg (ANDA)
|
ScieGen Pharmaceuticals, Inc. |
FLUOXETINE HYDROCHLORIDE |
D00823
|
|
ziprasidone capsule 60 mg (ANDA)
|
REMEDYREPACK INC. |
ziprasidone |
D01939
|
|
Quetiapine Fumarate tablet, film coated 25 mg (ANDA)
|
Bryant Ranch Prepack |
Quetiapine Fumarate |
D00458
|
|
Clopidogrel tablet, film coated 300 mg (ANDA)
|
Major Pharmaceuticals |
clopidogrel bisulfate |
D00769
|
Cyclobenzaprine Hydrochloride tablet, film coated 5 mg (ANDA)
Cyclobenzaprine Hydrochloride tablet, film coated 10 mg (ANDA)
|
Major Pharmaceuticals |
Cyclobenzaprine Hydrochloride |
D00772
|
|
Bivalirudin injection, powder, lyophilized, for solution 250 mg (ANDA)
|
Fresenius Kabi USA, LLC |
Bivalirudin |
D11280
|
|
Sodium Oxybate solution 500 mg/mL (ANDA)
|
Amneal Pharmaceuticals LLC |
Sodium Oxybate |
D05866
|
|
dexamethasone tablet 2 mg (ANDA)
|
Major Pharmaceuticals |
dexamethasone |
D00292
|
|
Losartan Potassium and Hydrochlorothiazide tablet, film coated 12.5 mg (ANDA)
|
Bryant Ranch Prepack |
Losartan Potassium and Hydrochlorothiazide |
D07895
|
|
Hydrocodone Bitartrate and Acetaminophen tablet 325 mg (ANDA)
|
Aurolife Pharma, LLC |
Hydrocodone Bitartrate and Acetaminophen |
D00846
|
Nitisinone capsule 2 mg (ANDA)
Nitisinone capsule 5 mg (ANDA)
Nitisinone capsule 10 mg (ANDA)
Nitisinone capsule 20 mg (ANDA)
|
Analog Pharma |
Nitisinone |
D05177
|
|
Galafold capsule 123 mg (NDA)
|
Amicus Therapeutics US, LLC |
migalastat hydrochloride |
D05031
|
|
Phytonadione injection, emulsion 1 mg/.5mL (ANDA)
|
Alembic Pharmaceuticals Limited |
Phytonadione |
D00148
|
|
MECLIZINE HYDROCHLORIDE tablet 12.5 mg (ANDA)
|
Bryant Ranch Prepack |
Meclizine Hydrochloride |
D01317
|
|
Tranexamic Acid injection, solution 100 mg/mL (ANDA)
|
Mylan Institutional LLC |
tranexamic acid |
D01136
|