| Product |
Company |
Generic name |
KEGG DRUG |
Fenofibric acid capsule, delayed release 45 mg (ANDA)
Fenofibric acid capsule, delayed release 135 mg (ANDA)
|
Micro Labs Limited |
Fenofibric acid |
D08890
|
Minocycline Hydrochloride tablet, film coated, extended release 90 mg (ANDA)
Minocycline Hydrochloride tablet, film coated, extended release 135 mg (ANDA)
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 115 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 55 mg (ANDA)
|
Ascend Laboratories, LLC |
Minocycline Hydrochloride |
D00850
|
XIFAXAN tablet 200 mg (NDA)
XIFAXAN tablet 550 mg (NDA)
|
Salix Pharmaceuticals, Inc. |
rifaximin |
D02554
|
Steritalc 2g powder 2 g/50mL (NDA)
Steritalc 3g powder 3 g0mL (NDA)
Steritalc 4g powder 4 g/50mL (NDA)
|
Novatech SA |
Talc |
D01084
|
|
MORPHINE SULFATE tablet 30 mg (ANDA)
|
Bryant Ranch Prepack |
MORPHINE SULFATE |
D00842
|
|
Isoproterenol Hydrochloride injection, solution .2 mg/mL (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
Isoproterenol Hydrochloride |
D01390
|
|
Gabapentin capsule 400 mg (ANDA)
|
A-S Medication Solutions |
Gabapentin |
D00332
|
|
Glimepiride tablet 1 mg (ANDA)
|
Bryant Ranch Prepack |
Glimepiride |
D00593
|
|
Endari powder, for solution 5 g (NDA)
|
Emmaus Medical, Inc. |
Glutamine |
D00015
|
|
Hydroxychloroquine sulfate tablet, film coated 200 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
Hydroxychloroquine sulfate |
D02114
|
|
Levetiracetam tablet, film coated 500 mg (ANDA)
|
REMEDYREPACK INC. |
Levetiracetam |
D00709
|
Venlafaxine Hydrochloride capsule, extended release 37.5 mg (ANDA)
Venlafaxine Hydrochloride capsule, extended release 75 mg (ANDA)
Venlafaxine Hydrochloride capsule, extended release 150 mg (ANDA)
|
American Health Packaging |
Venlafaxine Hydrochloride |
D00821
|
Nifedipine tablet, extended release 90 mg (ANDA)
Nifedipine tablet, extended release 30 mg (ANDA)
Nifedipine tablet, extended release 60 mg (ANDA)
|
Ascend Laboratories, LLC |
Nifedipine |
D00437
|
tadalafil tablet, film coated 2.5 mg (ANDA)
tadalafil tablet, film coated 5 mg (ANDA)
tadalafil tablet, film coated 10 mg (ANDA)
tadalafil tablet, film coated 20 mg (ANDA)
|
Asclemed USA, Inc. |
tadalafil |
D02008
|
|
Fluorouracil injection, solution 50 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
FLUOROURACIL |
D00584
|
|
Irbesartan tablet 150 mg (ANDA)
|
REMEDYREPACK INC. |
Irbesartan |
D00523
|
|
DICYCLOMINE HYDROCHLORIDE capsule 10 mg (ANDA)
|
Rising Pharma Holdings, Inc. |
DICYCLOMINE HYDROCHLORIDE |
D00717
|
Etodolac tablet, extended release 400 mg (ANDA)
Etodolac tablet, extended release 500 mg (ANDA)
Etodolac tablet, extended release 600 mg (ANDA)
|
NORTHSTAR RX LLC |
Etodolac |
D00315
|
|
Diazepam tablet 5 mg (ANDA)
|
REMEDYREPACK INC. |
Diazepam |
D00293
|
|
Xylocaine injection, solution 20 mg/mL (NDA)
|
ASCLEMED USA INC |
LIDOCAINE HYDROCHLORIDE |
D02086
|
|
PREDNISONE tablet 20 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
PREDNISONE |
D00473
|
Keppra XR tablet, film coated, extended release 500 mg (NDA)
Keppra XR tablet, film coated, extended release 750 mg (NDA)
|
UCB, Inc. |
levetiracetam |
D00709
|
Tetracycline Hydrochloride capsule 250 mg (ANDA)
Tetracycline Hydrochloride capsule 500 mg (ANDA)
|
Actavis Pharma, Inc. |
Tetracycline Hydrochloride |
D02122
|
Levothyroxine Sodium tablet .025 mg (ANDA)
Levothyroxine Sodium tablet .05 mg (ANDA)
Levothyroxine Sodium tablet .075 mg (ANDA)
Levothyroxine Sodium tablet .088 mg (ANDA)
Levothyroxine Sodium tablet .1 mg (ANDA)
Levothyroxine Sodium tablet .112 mg (ANDA)
Levothyroxine Sodium tablet .125 mg (ANDA)
Levothyroxine Sodium tablet .15 mg (ANDA)
Levothyroxine Sodium tablet .175 mg (ANDA)
|
Major Pharmaceuticals |
Levothyroxine Sodium |
D01010
|
|
Analpram HC cream 10 mg/g (ANDA)
|
Legacy Pharma USA Inc. |
hydrocortisone acetate and pramoxine hydrochloride |
D11657
|
RETACRIT injection, solution 2000 [iU]/mL (BLA)
RETACRIT injection, solution 3000 [iU]/mL (BLA)
RETACRIT injection, solution 4000 [iU]/mL (BLA)
RETACRIT injection, solution 10000 [iU]/mL (BLA)
RETACRIT injection, solution 40000 [iU]/mL (BLA)
RETACRIT injection, solution 20000 [iU]/mL (BLA)
|
Pfizer Laboratories Div Pfizer Inc |
epoetin alfa-epbx |
D03231
|
|
Finasteride tablet, film coated 5 mg (ANDA)
|
Cardinal Health 107, LLC |
Finasteride |
D00321
|
|
Lidocaine Hydrochloride injection, solution 20 mg/mL (ANDA)
|
Sportpharm, Inc. dba Sportpharm |
Lidocaine Hydrochloride |
D02086
|
|
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL kit (ANDA)
|
Mylan Pharmaceuticals Inc. |
norethindrone acetate and ethinyl estradiol |
D04483
|
|
Amantadine HCl capsule, liquid filled 100 mg (ANDA)
|
AvPAK |
AMANTADINE HYDROCHLORIDE |
D00777
|
SELZENTRY tablet, film coated 150 mg (NDA)
SELZENTRY tablet, film coated 300 mg (NDA)
SELZENTRY kit (NDA)
|
ViiV Healthcare Company |
maraviroc |
D06670
|
|
Metronidazole tablet, film coated 500 mg (ANDA)
|
REMEDYREPACK INC. |
Metronidazole |
D00409
|
PRUCALOPRIDE tablet, film coated 1 mg (ANDA)
PRUCALOPRIDE tablet, film coated 2 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
PRUCALOPRIDE |
D10152
|
|
Metformin tablet, extended release 500 mg (ANDA)
|
REMEDYREPACK INC. |
Metformin ER 500 mg |
D00944
|
|
Glyburide tablet 5 mg (ANDA)
|
REMEDYREPACK INC. |
Glyburide |
D00336
|
Levetiracetam injection 500 mg00mL (ANDA)
Levetiracetam injection 1000 mg00mL (ANDA)
Levetiracetam injection 1500 mg00mL (ANDA)
|
Caplin Steriles Limited |
Levetiracetam in Sodium Chloride |
D00709
|
Clozapine tablet, orally disintegrating 25 mg (ANDA)
Clozapine tablet, orally disintegrating 100 mg (ANDA)
Clozapine tablet, orally disintegrating 12.5 mg (ANDA)
Clozapine tablet, orally disintegrating 150 mg (ANDA)
Clozapine tablet, orally disintegrating 200 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Clozapine |
D00283
|
|
Ondansetron tablet, orally disintegrating 8 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Ondansetron |
D00456
|
|
Loxapine capsule 10 mg (ANDA)
|
REMEDYREPACK INC. |
Loxapine |
D00794
|
|
Amitriptyline Hydrochloride tablet 100 mg (ANDA)
|
A-S Medication Solutions |
Amitriptyline Hydrochloride |
D00809
|