| Product |
Company |
Generic name |
KEGG DRUG |
|
Metoprolol Succinate tablet, extended release 50 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Metoprolol Succinate |
D00635
|
|
Amitriptyline Hydrochloride tablet, film coated 50 mg (ANDA)
|
A-S Medication Solutions |
Amitriptyline Hydrochloride |
D00809
|
|
Pregabalin capsule 75 mg (ANDA)
|
Proficient Rx LP |
Pregabalin |
D02716
|
Morphine Sulfate injection, solution 10 mg/mL (NDA)
Morphine Sulfate injection, solution 2 mg/mL (NDA)
Morphine Sulfate injection, solution 4 mg/mL (NDA)
Morphine Sulfate injection, solution 5 mg/mL (NDA)
Morphine Sulfate injection, solution 8 mg/mL (NDA)
|
Fresenius Kabi USA, LLC |
Morphine Sulfate |
D00842
|
Lactulose powder, for solution 10 g0g (ANDA)
Lactulose powder, for solution 20 g/20g (ANDA)
|
PAI Holdings, LLC dba PAI Pharma |
Lactulose |
D00352
|
|
DICLOFENAC SODIUM gel 30 mg/g (ANDA)
|
Preferred Pharmaceuticals Inc. |
diclofenac sodium |
D00904
|
ENALAPRIL MALEATE tablet 2.5 mg (ANDA)
ENALAPRIL MALEATE tablet 5 mg (ANDA)
ENALAPRIL MALEATE tablet 10 mg (ANDA)
ENALAPRIL MALEATE tablet 20 mg (ANDA)
|
ScieGen Pharmaceuticals, Inc. |
ENALAPRIL MALEATE |
D00621
|
|
diclofenac sodium gel 30 mg/g (ANDA)
|
Preferred Pharmaceuticals Inc. |
diclofenac sodium |
D00904
|
|
Gabapentin capsule 300 mg (ANDA)
|
Proficient Rx LP |
Gabapentin |
D00332
|
NEOSTIGMINE METHYLSULFATE injection .5 mg/mL (ANDA)
NEOSTIGMINE METHYLSULFATE injection 1 mg/mL (ANDA)
|
Indoco Remedies Limited |
NEOSTIGMINE METHYLSULFATE |
D00998
|
|
Cayston kit (NDA)
|
Gilead Sciences, Inc. |
aztreonam |
D00240
|
|
Felbamate tablet 400 mg (ANDA)
|
Bryant Ranch Prepack |
Felbamate |
D00536
|
|
Diclofenac Sodium gel 30 mg/g (ANDA)
|
Preferred Pharmaceuticals Inc. |
Diclofenac Sodium Topical |
D00904
|
|
Nifedipine tablet, film coated, extended release 60 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Nifedipine |
D00437
|
|
Levocarnitine solution 1 g0mL (ANDA)
|
Saptalis Pharmaceuticals, LLC |
Levocarnitine Oral |
D02176
|
|
ProHance injection, solution 279.3 mg/mL (NDA)
|
BRACCO DIAGNOSTICS INC |
gadoteridol |
D01137
|
|
Oxygen gas 999 mL/L (NDA)
|
Baker's Gas & Welding Supplies Inc. |
Oxygen |
D00003
|
Prograf capsule, gelatin coated .5 mg (NDA)
Prograf capsule, gelatin coated 1 mg (NDA)
Prograf capsule, gelatin coated 5 mg (NDA)
Prograf injection, solution 5 mg/mL (NDA)
Prograf granule, for suspension .2 mg (NDA)
Prograf granule, for suspension 1 mg (NDA)
|
Astellas Pharma US, Inc. |
Tacrolimus |
D00107
|
|
DOTAREM injection 376.9 mg/mL (NDA)
|
Guerbet LLC |
gadoterate meglumine |
D03355
|
|
Valacyclovir Hydrochloride tablet, film coated 500 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Valacyclovir Hydrochloride |
D00398
|
|
Propranolol Hydrochloride tablet 10 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Propranolol Hydrochloride |
D00483
|
Meclizine Hydrochloride tablet, film coated 12.5 mg (ANDA)
Meclizine Hydrochloride tablet, film coated 25 mg (ANDA)
Meclizine Hydrochloride tablet, film coated 50 mg (ANDA)
|
Chartwell RX, LLC |
Meclizine Hydrochloride |
D01317
|
|
Diclofenac Sodium solution 16.05 mg/mL (ANDA)
|
Preferred Pharmaceuticals Inc. |
Diclofenac |
D00904
|
|
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate capsule, extended release 3.75 mg (ANDA)
|
Bryant Ranch Prepack |
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate |
D11624
|
|
Diclofenac Sodium gel 10 mg/g (ANDA)
|
Preferred Pharmaceuticals, Inc. |
Diclofenac Sodium Topical Gel, 1%, |
D00904
|
Fluoxetine capsule 20 mg (ANDA)
Fluoxetine capsule 10 mg (ANDA)
|
Legacy Pharmaceutical Packaging, LLC |
Fluoxetine |
D00823
|
LURASIDONE HYDROCHLORIDE tablet 20 mg (ANDA)
LURASIDONE HYDROCHLORIDE tablet 40 mg (ANDA)
LURASIDONE HYDROCHLORIDE tablet 60 mg (ANDA)
LURASIDONE HYDROCHLORIDE tablet 80 mg (ANDA)
LURASIDONE HYDROCHLORIDE tablet 120 mg (ANDA)
|
Aurobindo Pharma Limited |
LURASIDONE HYDROCHLORIDE |
D04820
|
|
dicyclomine hydrochloride solution 10 mg/5mL (ANDA)
|
Endo USA, Inc. |
dicyclomine hydrochloride |
D00717
|
|
Olanzapine injection, powder, for solution 10 mg/2mL (ANDA)
|
Sandoz Inc |
Olanzapine |
D00454
|
Pioglitazone tablet 15 mg (ANDA)
Pioglitazone tablet 30 mg (ANDA)
Pioglitazone tablet 45 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Pioglitazone |
D00945
|
|
Levetiracetam tablet 500 mg (ANDA)
|
A-S Medication Solutions |
Levetiracetam |
D00709
|
Pirfenidone tablet, film coated 267 mg (ANDA)
Pirfenidone tablet, film coated 801 mg (ANDA)
|
Teva Pharmaceuticals, Inc. |
Pirfenidone |
D01583
|
|
Arformoterol tartrate solution 15 ug/2mL (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Arformoterol tartrate |
D02981
|
|
Eszopiclone tablet, film coated 1 mg (ANDA)
|
Proficient Rx LP |
Eszopiclone |
D02624
|
Provigil tablet 100 mg (NDA)
Provigil tablet 200 mg (NDA)
|
Cephalon, LLC |
Modafinil |
D01832
|
|
DOTAREM injection 376.9 mg/mL (NDA)
|
Guerbet LLC |
gadoterate meglumine |
D03355
|
|
Metronidazole gel 10 mg/g (ANDA)
|
Alembic Pharmaceuticals Limited |
Metronidazole |
D00409
|
|
Metronidazole injection, solution 500 mg00mL (ANDA)
|
WG Critical Care, LLC |
Metronidazole |
D00409
|
|
ProHance injection, solution 279.3 mg/mL (NDA)
|
Bracco Diagnostics Inc |
gadoteridol |
D01137
|
|
CHLORZOXAZONE tablet 250 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
CHLORZOXAZONE |
D00771
|