telmisartan

Basic Information

Product Name

telmisartan

FDA Product Code

71335-1428

Regulatory Information

NDC Product Code

71335-1428

Application Number

ANDA205150

Marketing Category

C73584

Effective Date

July 1, 2020

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use TELMISARTAN TABLETS safely and effectively. See full prescribing information for TELMISARTAN TABLETS. TELMISARTAN tablets, for oral use Initial U.S. Approval: 1998

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

MEGLUMINE

Code: 6HG8UB2MUY

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

SODIUM STEARYL FUMARATE

Code: 7CV7WJK4UI

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

TELMISARTAN

Quantity: 80 mg in 1 1

Code: U5SYW473RQ

Class Code: ACTIB

Active Moieties

Code: U5SYW473RQ

telmisartan

Basic Information

Regulatory Information

Company Information

Active Ingredients

MEGLUMINE

SODIUM HYDROXIDE

MANNITOL

SODIUM STEARYL FUMARATE

MAGNESIUM STEARATE

POVIDONE, UNSPECIFIED

Active Moieties

TELMISARTAN