USFDA APPLICATION NUMBER - 21956 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
---|---|---|
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) | HYDROCHLOROTHIAZIDE | 12.5mg | 12.5mg | 12.5mg |
METOPROLOL SUCCINATE(UNII: TH25PD4CCB) (METOPROLOL - UNII:GEB06NHM23) | METOPROLOL | 100mg | 50mg | 25mg |
Inactive Ingredients
Ingredient Name | AstraZeneca Pharmaceuticals LP | Concordia Pharmaceuticals Inc. | Covis Pharmaceuticals Inc | Solubiomix |
---|---|---|---|---|
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||
ETHYLCELLULOSES(7Z8S9VYZ4B) | ||||
FERRIC OXIDE RED(1K09F3G675) | ||||
FERRIC OXIDE YELLOW(EX438O2MRT) | ||||
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | ||||
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) | ||||
HYDROXYPROPYL CELLULOSE(RFW2ET671P) | ||||
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||
HYPROMELLOSES(3NXW29V3WO) | ||||
PARAFFIN(I9O0E3H2ZE) | ||||
POLYETHYLENE GLYCOL 6000(30IQX730WE) | ||||
POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | ||||
POVIDONE K15(E54VE15114) | ||||
SILICON DIOXIDE(ETJ7Z6XBU4) | ||||
SODIUM STEARYL FUMARATE(7CV7WJK4UI) | ||||
STARCH, CORN(O8232NY3SJ) | ||||
TITANIUM DIOXIDE(15FIX9V2JP) |
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