USFDA APPLICATION NUMBER - 19839 / DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
sertraline hydrochloride(UNII: UTI8907Y6X) (sertraline - UNII:QUC7NX6WMB) | sertraline hydrochloride | 100mg |
Inactive Ingredients
Ingredient Name | REMEDYREPACK INC. | Aphena Pharma Solutions - Tennessee, LLC | Bryant Ranch Prepack | Cardinal Health | KAISER FOUNDATION HOSPITALS | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | PD-Rx Pharmaceuticals, Inc. |
---|---|---|---|---|---|---|---|
ALCOHOL, X-RAY EXPOSED (1000 RAD)(6PRJ93602P) | |||||||
ALUMINUM OXIDE(LMI26O6933) | |||||||
AMMONIUM LAURETH-5 SULFATE(43ZIH89I48) | |||||||
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K) | |||||||
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(O7TSZ97GEP) | |||||||
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||
D&C YELLOW NO. 10(35SW5USQ3G) | |||||||
dibasic calcium phosphate dihydrate(O7TSZ97GEP) | |||||||
FD&C BLUE NO. 1(H3R47K3TBD) | |||||||
FD&C BLUE NO. 2(L06K8R7DQK) | |||||||
FD&C RED NO. 40(WZB9127XOA) | |||||||
ferric oxide yellow(EX438O2MRT) | |||||||
GLYCERIN(PDC6A3C0OX) | |||||||
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P) | |||||||
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | |||||||
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) | |||||||
HYDROXYPROPYL CELLULOSE(RFW2ET671P) | |||||||
hypromellose(3NXW29V3WO) | |||||||
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||||||
HYPROMELLOSES(3NXW29V3WO) | |||||||
MAGNESIUM STEARATE(70097M6I30) | |||||||
MENTHOL 1-PROPYLENE GLYCOL CARBONATE, (-)-(2WL8FX4EEZ) | |||||||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||
polyethylene glycol(3WJQ0SDW1A) | |||||||
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||||||
POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | |||||||
polysorbate 80(6OZP39ZG8H) | |||||||
TITANIUM DIOXIDE(15FIX9V2JP) |
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