Application Nr Approved Date Route Status External Links
ANDA203010 2014-02-25 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Telmisartan And Hydrochlorothiazide Tablets, Usp Are Indicated For The Treatment Of Hypertension. This Fixed Dose Combination Is Not Indicated For Initial Therapy (see Dosage And Administration).

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
2. Sodium Hydroxide SODIUM HYDROXIDE Unresolved BC-Boiler compound , B&N-Buffer & neutralizing agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
3. Meglumine MEGLUMINE Molecular
4. Povidones POVIDONES Unresolved
5. Sodium Stearyl Fumarate SODIUM STEARYL FUMARATE Molecular MISC-Miscellaneous , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.
6. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
7. 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.

Active Ingredients ( 2 Total)

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