| Product |
Company |
Generic name |
KEGG DRUG |
EPINEPHRINE injection 1 mg/mL (NDA)
EPINEPHRINE injection 30 mg/30mL (NDA)
|
BPI Labs, LLC |
EPINEPHRINE |
D00095
|
|
Minocycline Hydrochloride tablet, film coated, extended release 45 mg (ANDA)
|
Bryant Ranch Prepack |
Minocycline Hydrochloride |
D00850
|
|
Trazodone Hydrochloride tablet 100 mg (ANDA)
|
NCS HealthCare of KY, LLC dba Vangard Labs |
Trazodone Hydrochloride |
D00820
|
Fenofibrate tablet 48 mg (ANDA)
Fenofibrate tablet 145 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Fenofibrate |
D00565
|
|
Succinylcholine Chloride injection, solution 20 mg/mL (ANDA)
|
REMEDYREPACK INC. |
Succinylcholine Chloride |
D00766
|
|
Fluphenazine Hydrochloride tablet, film coated 5 mg (ANDA)
|
REMEDYREPACK INC. |
Fluphenazine Hydrochloride |
D00791
|
|
Chlorpromazine Hydrochloride tablet, coated 100 mg (ANDA)
|
REMEDYREPACK INC. |
Chlorpromazine Hydrochloride |
D00789
|
|
telmisartan tablet 80 mg (ANDA)
|
REMEDYREPACK INC. |
telmisartan |
D00627
|
|
Clopidogrel tablet 75 mg (ANDA)
|
Amneal Pharmaceuticals LLC |
Clopidogrel |
D00769
|
|
FAMOTIDINE powder, for suspension 40 mg/5mL (ANDA)
|
Micro Labs Limited |
FAMOTIDINE |
D00318
|
|
Ethosuximide solution 250 mg/5mL (ANDA)
|
Mylan Pharmaceuticals Inc. |
Ethosuximide |
D00539
|
Buprenorphine patch, extended release 5 ug/h (ANDA)
Buprenorphine patch, extended release 7.5 ug/h (ANDA)
Buprenorphine patch, extended release 10 ug/h (ANDA)
Buprenorphine patch, extended release 15 ug/h (ANDA)
Buprenorphine patch, extended release 20 ug/h (ANDA)
|
Aveva Drug Delivery Systems Inc. |
Buprenorphine |
D07132
|
Midazolam injection, solution 1 mg/mL (ANDA)
Midazolam injection, solution 5 mg/mL (ANDA)
|
Hospira, Inc. |
MIDAZOLAM HYDROCHLORIDE |
D00696
|
|
Labetalol Hydrochloride tablet, film coated 300 mg (ANDA)
|
RedPharm Drug |
Labetalol Hydrochloride |
D00600
|
|
ALLOPURINOL tablet 300 mg (ANDA)
|
REMEDYREPACK INC. |
ALLOPURINOL |
D00224
|
|
MYCOPHENOLATE MOFETIL powder, for suspension 200 mg/mL (ANDA)
|
Aurobindo Pharma Limited |
mycophenolate mofetil |
D00752
|
|
Morphine Sulfate solution 20 mg/mL (ANDA)
|
SpecGx LLC |
morphine sulfate |
D00842
|
Tizanidine tablet 2 mg (ANDA)
Tizanidine tablet 4 mg (ANDA)
|
Asclemed USA, Inc. |
Tizanidine |
D00776
|
|
DALFAMPRIDINE tablet, extended release 10 mg (ANDA)
|
Micro Labs Limited |
DALFAMPRIDINE |
D04127
|
Trazodone Hydrochloride tablet 50 mg (ANDA)
Trazodone Hydrochloride tablet 150 mg (ANDA)
|
NCS HealthCare of KY, LLC dba Vangard Labs |
Trazodone Hydrochloride |
D00820
|
|
Divalproex Sodium tablet, extended release 500 mg (ANDA)
|
REMEDYREPACK INC. |
Divalproex Sodium |
D00304
|
|
Allopurinol tablet 100 mg (ANDA)
|
REMEDYREPACK INC. |
Allopurinol |
D00224
|
TERBUTALINE SULFATE tablet 2.5 mg (ANDA)
TERBUTALINE SULFATE tablet 5 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC |
TERBUTALINE SULFATE |
D00688
|
|
MiCort HC Cream cream 20 mg/g (ANDA)
|
Legacy Pharma USA Inc. |
Hydrocortisone Acetate Cream |
D00165
|
|
Valacyclovir tablet, film coated 500 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Valacyclovir |
D00398
|
|
Labetalol Hydrochloride tablet, film coated 200 mg (ANDA)
|
NuCare Pharmaceuticals , Inc. |
Labetalol Hydrochloride |
D00600
|
|
Divalproex Sodium D/R tablet, delayed release 250 mg (ANDA)
|
Direct_Rx |
Divalproex Sodium D/R |
D00304
|
|
Hydrocortisone Acetate Cream cream 20 mg/g (ANDA)
|
Allegis Holdings LLC |
Hydrocortisone Acetate Cream |
D00165
|
|
Vardenafil Hydrochloride tablet 5 mg (ANDA)
|
AvKARE |
Vardenafil Hydrochloride |
D03260
|
|
Losartan Potassium tablet, film coated 25 mg (ANDA)
|
REMEDYREPACK INC. |
Losartan Potassium |
D00357
|
|
ACETADOTE injection, solution 200 mg/mL (NDA)
|
Cumberland Pharmaceuticals Inc. |
Acetylcysteine |
D00221
|
Cytotec tablet 100 ug (NDA)
Cytotec tablet 200 ug (NDA)
|
Pfizer Laboratories Div Pfizer Inc |
misoprostol |
D00419
|
Oxycodone Hydrochloride solution 5 mg/5mL (ANDA)
Oxycodone Hydrochloride solution 100 mg/5mL (ANDA)
|
SpecGx LLC |
Oxycodone Hydrochloride |
D00847
|
Trazodone Hydrochloride tablet 50 mg (ANDA)
Trazodone Hydrochloride tablet 100 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Trazodone Hydrochloride |
D00820
|
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)
|
Alembic Pharmaceuticals Inc. |
VENLAFAXINE HYDROCHLORIDE |
D00821
|
|
XOPENEX HFA aerosol, metered 45 ug (NDA)
|
Lupin Pharmaceuticals, Inc. |
levalbuterol tartrate |
D04703
|
Clobazam tablet 10 mg (ANDA)
Clobazam tablet 20 mg (ANDA)
|
Micro Labs Limited |
Clobazam |
D01253
|
FENTANYL patch, extended release 12 ug/h (ANDA)
FENTANYL patch, extended release 25 ug/h (ANDA)
FENTANYL patch, extended release 37.5 ug/h (ANDA)
FENTANYL patch, extended release 50 ug/h (ANDA)
FENTANYL patch, extended release 62.5 ug/h (ANDA)
FENTANYL patch, extended release 75 ug/h (ANDA)
FENTANYL patch, extended release 87.5 ug/h (ANDA)
FENTANYL patch, extended release 100 ug/h (ANDA)
|
Aveva Drug Delivery Systems Inc. |
FENTANYL |
D00320
|
|
fluticasone propionate and salmeterol powder 100 ug (ANDA)
|
REMEDYREPACK INC. |
fluticasone propionate and salmeterol |
D08699
|
|
Simvastatin tablet, film coated 10 mg (ANDA)
|
REMEDYREPACK INC. |
Simvastatin |
D00434
|