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FDA Approval

Telmisartan

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
AvKARE
DUNS: 796560394
Effective Date
January 10, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Telmisartan(40 mg in 1 1)

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Telmisartan

Product Details

NDC Product Code
42291-791
Application Number
ANDA204415
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 10, 2024
MEGLUMINEInactive
Code: 6HG8UB2MUYClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
Code: U5SYW473RQClass: ACTIBQuantity: 40 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT

Telmisartan

Product Details

NDC Product Code
42291-790
Application Number
ANDA204415
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 10, 2024
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUYClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
Code: U5SYW473RQClass: ACTIBQuantity: 20 mg in 1 1

Telmisartan

Product Details

NDC Product Code
42291-792
Application Number
ANDA204415
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 10, 2024
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUYClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: U5SYW473RQClass: ACTIBQuantity: 80 mg in 1 1
TALCInactive
Code: 7SEV7J4R1UClass: IACT
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