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FDA Drug information

Telmisartan

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20221031

Version

7

Spl Product Data Elements

telmisartan telmisartan TELMISARTAN TELMISARTAN FERRIC OXIDE RED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MEGLUMINE POVIDONE SODIUM HYDROXIDE SODIUM STEARYL FUMARATE SORBITOL MOTTLED LIGHT BROWN TO MOTTLED BROWN ROUND 471 telmisartan telmisartan TELMISARTAN TELMISARTAN SODIUM HYDROXIDE MEGLUMINE POVIDONE LACTOSE MONOHYDRATE FERRIC OXIDE RED SORBITOL SODIUM STEARYL FUMARATE MAGNESIUM STEARATE MOTTLED LIGHT BROWN TO MOTTLED BROWN OBLONG 472 telmisartan telmisartan TELMISARTAN TELMISARTAN SODIUM HYDROXIDE MEGLUMINE POVIDONE LACTOSE MONOHYDRATE FERRIC OXIDE RED SORBITOL SODIUM STEARYL FUMARATE MAGNESIUM STEARATE MOTTLED LIGHT BROWN TO MOTTLED BROWN OBLONG 473

Application Number

ANDA203325

Brand Name

Telmisartan

Generic Name

telmisartan

Product Ndc

65841-806

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-804-05 in bottle of 500 tablets Telmisartan Tablets USP, 20 mg R x only 500 tablets NDC 65841-805-05 in bottle of 500 tablets Telmisartan Tablets USP, 40 mg R x only 500 tablets NDC 65841-806-05 in bottle of 500 tablets Telmisartan Tablets USP, 80 mg R x only 500 tablets Telmisartan tablets, 20 mg Telmisartan Tablets, 40 mg Telmisartan Tablets, 80 mg

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