Application Nr Approved Date Route Status External Links
ANDA202870 2013-11-06 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Metoprolol Tartrate And Hydrochlorothiazide Tablets Are Indicated For The Management Of Hypertension. This Fixed-Combination Drug Is Not Indicated For Initial Therapy Of Hypertension. If The Fixed Combination Represents The Dose Titrated To The Individual Patient’s Needs, Therapy With The Fixed Combination May Be More Convenient Than With The Separate Components.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Povidones POVIDONES Unresolved
5. Lactose, Unspecified Form LACTOSE, UNSPECIFIED FORM Molecular

Active Ingredients ( 2 Total)