| Product |
Company |
Generic name |
KEGG DRUG |
QELBREE capsule, extended release 100 mg (NDA)
QELBREE capsule, extended release 150 mg (NDA)
QELBREE capsule, extended release 200 mg (NDA)
|
Supernus Pharmaceuticals, Inc |
viloxazine hydrochloride |
D02572
|
|
Larin 1/20 kit (ANDA)
|
Northstar Rx LLC |
Norethindrone Acetate/Ethinyl Estradiol |
D04483
|
|
Nystatin cream 100000 [USP'U]/g (ANDA)
|
Bryant Ranch Prepack |
Nystatin |
D00202
|
|
Oxygen gas 992 mL/L (NDA)
|
AMERICAN MEDICAL GAS RESOURCES LLC |
Oxygen |
D00003
|
|
PIMTREA kit (ANDA)
|
Northstar Rx LLC |
desogestrel/ethinyl estradiol and ethinyl estradiol |
D00484
|
|
Tri-Linyah kit (ANDA)
|
Northstar Rx LLC |
Norgestimate and Ethinyl Estradiol |
D10590
|
|
SETLAKIN kit (ANDA)
|
Northstar Rx LLC |
Levonorgestrel and Ethinyl Estradiol |
D04482
|
|
Nitrogen gas 999 mL/L (NDA)
|
WEST PENN LACO, INC. |
Nitrogen |
D00083
|
|
Oxygen gas 998 mL/L (NDA)
|
WEST PENN LACO, INC. |
Oxygen |
D00003
|
|
Oxygen gas 990 mL/L (NDA)
|
TIMS SOUTH TEXAS LLC |
Oxygen |
D00003
|
Carbamazepine ER tablet, extended release 100 mg (ANDA)
Carbamazepine ER tablet, extended release 200 mg (ANDA)
Carbamazepine ER tablet, extended release 400 mg (ANDA)
|
Chartwell RX, LLC |
Carbamazepine ER |
D00252
|
|
Dasetta 1/35 kit (ANDA)
|
Northstar Rx LLC |
Norethindrone and Ethinyl Estradiol |
D04483
|
Benztropine Mesylate tablet 2 mg (ANDA)
Benztropine Mesylate tablet 1 mg (ANDA)
Benztropine Mesylate tablet .5 mg (ANDA)
|
Chartwell RX, LLC. |
Benztropine mesylate |
D00778
|
Rozlytrek capsule 100 mg (NDA)
Rozlytrek capsule 200 mg (NDA)
Rozlytrek pellet 50 mg/201 (NDA)
|
Genentech, Inc. |
ENTRECTINIB |
D10926
|
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)
|
NIVAGEN PHARMACEUTICALS, INC. |
Tadalafil |
D02008
|
Buspirone Hydrochloride tablet 5 mg (ANDA)
Buspirone Hydrochloride tablet 10 mg (ANDA)
Buspirone Hydrochloride tablet 15 mg (ANDA)
Buspirone Hydrochloride tablet 30 mg (ANDA)
Buspirone Hydrochloride tablet 7.5 mg (ANDA)
|
Strides Pharma Science Limited |
Buspirone Hydrochloride |
D00702
|
Acarbose tablet 25 mg (ANDA)
Acarbose tablet 50 mg (ANDA)
Acarbose tablet 100 mg (ANDA)
|
Chartwell RX, LLC |
acarbose |
D00216
|
|
Indomethacin capsule 50 mg (ANDA)
|
Chartwell RX, LLC |
Indomethacin |
D00141
|
|
Carvedilol tablet, film coated 6.25 mg (ANDA)
|
Proficient Rx LP |
Carvedilol |
D00255
|
|
EXTRANEAL injection, solution 7.5 g00mL (NDA)
|
Vantive US Healthcare LLC |
icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride |
|
BACLOFEN injection 500 ug/mL (ANDA)
BACLOFEN injection 1000 ug/mL (ANDA)
BACLOFEN injection 2000 ug/mL (ANDA)
|
Advagen Pharma Limited |
Baclofen |
D00241
|
Methadone Hydrochloride tablet 5 mg (ANDA)
Methadone Hydrochloride tablet 10 mg (ANDA)
|
Elite Laboratories, Inc. |
Methadone Hydrochloride |
D02102
|
|
Anastrozole tablet 1 mg (ANDA)
|
Chartwell RX, LLC |
Anastrozole |
D00960
|
TRAMADOL HYDROCHLORIDE tablet, extended release 100 mg (ANDA)
TRAMADOL HYDROCHLORIDE tablet, extended release 200 mg (ANDA)
TRAMADOL HYDROCHLORIDE tablet, extended release 300 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
TRAMADOL HYDROCHLORIDE |
D01355
|
Acetazolamide tablet 125 mg (ANDA)
Acetazolamide tablet 250 mg (ANDA)
|
Aarkish Pharmaceuticals NJ Inc. |
Acetazolamide |
D00218
|
|
Larin 1.5/30 kit (ANDA)
|
Northstar Rx LLC |
Norethindrone Acetate/Ethinyl Estradiol |
D04483
|
|
Propranolol Hydrochloride tablet 10 mg (ANDA)
|
Proficient Rx LP |
Propranolol Hydrochloride |
D00483
|
Carbamazepine tablet 100 mg (ANDA)
Carbamazepine tablet 200 mg (ANDA)
|
NIVAGEN PHARMACEUTICALS, INC. |
Carbamazepine |
D00252
|
|
Larin Fe 1/20 kit (ANDA)
|
Northstar Rx LLC |
Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate |
D04483
|
|
DEBLITANE kit (ANDA)
|
Northstar Rx LLC |
Norethindrone |
D00182
|
|
Tacrolimus capsule 1 mg (ANDA)
|
Cardinal Health 107, LLC |
Tacrolimus |
D00107
|
|
Larin 24 Fe kit (ANDA)
|
Northstar Rx LLC |
Norethindrone acetate/Ethinyl Estradiol and Ferrous Fumarate |
D04483
|
|
ODEFSEY tablet 200 mg (NDA)
|
Gilead Sciences, Inc. |
emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide |
D10836
|
|
Larin Fe 1.5/30 kit (ANDA)
|
Northstar Rx LLC |
Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate |
D04483
|
|
tizanidine tablet 4 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
tizanidine |
D00776
|
Etodolac tablet, film coated 400 mg (ANDA)
Etodolac tablet, film coated 500 mg (ANDA)
|
Chartwell RX, LLC |
Etodolac |
D00315
|
|
Pravastatin sodium tablet 10 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Pravastatin sodium |
D00893
|
Deflazacort tablet 6 mg (ANDA)
Deflazacort tablet 18 mg (ANDA)
Deflazacort tablet 30 mg (ANDA)
Deflazacort tablet 36 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Deflazacort |
D03671
|
|
Gabapentin tablet, film coated 600 mg (ANDA)
|
REMEDYREPACK INC. |
Gabapentin |
D00332
|
|
Oxygen gas 999 mL/L (NDA)
|
HELGET, INC. |
Oxygen |
D00003
|