| Product |
Company |
Generic name |
KEGG DRUG |
|
Labetalol HCL tablet, film coated 200 mg (ANDA)
|
A-S Medication Solutions |
Labetalol Hydrochloride |
D00600
|
|
Buspirone HCL tablet 15 mg (ANDA)
|
Direct_Rx |
Buspirone HCL |
D00702
|
|
LUTRATE DEPOT kit (NDA)
|
Avyxa Pharma, LLC |
leuprolide acetate |
D00989
|
|
Fexmid tablet 7.5 mg (ANDA)
|
Rising Pharma Holdings, Inc. |
Cyclobenzaprine Hydrochloride |
D00772
|
Capecitabine tablet, film coated 150 mg (ANDA)
Capecitabine tablet, film coated 500 mg (ANDA)
|
CivicaScript LLC |
Capecitabine |
D01223
|
Amitriptyline Hydrochloride tablet, film coated 10 mg (ANDA)
Amitriptyline Hydrochloride tablet, film coated 25 mg (ANDA)
Amitriptyline Hydrochloride tablet, film coated 50 mg (ANDA)
Amitriptyline Hydrochloride tablet, film coated 75 mg (ANDA)
Amitriptyline Hydrochloride tablet, film coated 100 mg (ANDA)
Amitriptyline Hydrochloride tablet, film coated 150 mg (ANDA)
|
Sandoz Inc |
Amitriptyline Hydrochloride |
D00809
|
|
scopolamine system 1 mg/3d (ANDA)
|
Actavis Pharma, Inc. |
scopolamine |
D00138
|
|
CORDRAN tape 4 ug/cm2 (NDA)
|
Almirall, LLC |
flurandrenolide |
D00328
|
|
MORPHINE SULFATE tablet 15 mg (ANDA)
|
Bryant Ranch Prepack |
MORPHINE SULFATE |
D00842
|
|
Atorvastatin Calcium tablet 40 mg (ANDA)
|
Bryant Ranch Prepack |
atorvastatin calcium, film coated |
D02258
|
Steritalc 2g powder 2 g/50mL (NDA)
Steritalc 3g powder 3 g0mL (NDA)
Steritalc 4g powder 4 g/50mL (NDA)
|
Novatech SA |
Talc |
D01084
|
|
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
|
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
|
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
|
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
|
|
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
|
PRUCALOPRIDE tablet, film coated 1 mg (ANDA)
PRUCALOPRIDE tablet, film coated 2 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
PRUCALOPRIDE |
D10152
|
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
|
|
Amitriptyline Hydrochloride tablet 100 mg (ANDA)
|
A-S Medication Solutions |
Amitriptyline Hydrochloride |
D00809
|
|
Valacyclovir tablet, film coated 500 mg (ANDA)
|
Proficient Rx LP |
Valacyclovir |
D10518
|
Zolpidem Tartrate tablet, coated 10 mg (ANDA)
Zolpidem Tartrate tablet, coated 5 mg (ANDA)
|
Proficient Rx LP |
Zolpidem Tartrate |
D00706
|
Estazolam tablet 1 mg (ANDA)
Estazolam tablet 2 mg (ANDA)
|
Actavis Pharma, Inc. |
Estazolam |
D00311
|
Ropivacaine Hydrochloride injection 2 mg/mL (ANDA)
Ropivacaine Hydrochloride injection 5 mg/mL (ANDA)
Ropivacaine Hydrochloride injection 10 mg/mL (ANDA)
|
Caplin Steriles Limited |
Ropivacaine Hydrochloride |
D04048
|
Simvastatin tablet, film coated 10 mg (ANDA)
Simvastatin tablet, film coated 20 mg (ANDA)
Simvastatin tablet, film coated 40 mg (ANDA)
Simvastatin tablet, film coated 80 mg (ANDA)
|
Westminster Pharmaceuticals, LLC |
Simvastatin |
D00434
|
Intuniv tablet, extended release 1 mg (NDA)
Intuniv tablet, extended release 2 mg (NDA)
Intuniv tablet, extended release 3 mg (NDA)
Intuniv tablet, extended release 4 mg (NDA)
|
Takeda Pharmaceuticals America, Inc. |
guanfacine |
D00606
|
|
Fulvestrant injection, solution 250 mg/5mL (ANDA)
|
BluePoint Laboratories |
Fulvestrant |
D01161
|
|
XIFYRM injection 30 mg/mL (NDA)
|
Azurity Pharmaceuticals, Inc. |
meloxicam |
D00969
|