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FDA Approval

AMLODIPINE AND OLMESARTAN MEDOXOMIL

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

FDA Approval Summary

Company

Micro Labs Limited

DUNS: 862174955

Effective Date

November 23, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Amlodipine(5 mg in 1 1)

Olmesartan(20 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Micro Labs Limited

Labeler

Micro Labs Limited

DUNS Number

915793658

Products4

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

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Details

NDC Product Code

42571-235

Application Number

ANDA207435

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 23, 2021

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

AmlodipineActive

Code: 864V2Q084HClass: ACTIMQuantity: 5 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

OlmesartanActive

Code: 6M97XTV3HDClass: ACTIBQuantity: 20 mg in 1 1

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Details

NDC Product Code

42571-236

Application Number

ANDA207435

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 23, 2021

Ingredients

POLYVINYL ALCOHOLInactive

Code: 532B59J990Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

AmlodipineActive

Code: 864V2Q084HClass: ACTIMQuantity: 10 mg in 1 1

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

OlmesartanActive

Code: 6M97XTV3HDClass: ACTIBQuantity: 20 mg in 1 1

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Details

NDC Product Code

42571-238

Application Number

ANDA207435

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 23, 2021

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

OlmesartanActive

Code: 6M97XTV3HDClass: ACTIBQuantity: 40 mg in 1 1

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

AmlodipineActive

Code: 864V2Q084HClass: ACTIMQuantity: 10 mg in 1 1

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Details

NDC Product Code

42571-237

Application Number

ANDA207435

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 23, 2021

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

AmlodipineActive

Code: 864V2Q084HClass: ACTIMQuantity: 5 mg in 1 1

OlmesartanActive

Code: 6M97XTV3HDClass: ACTIBQuantity: 40 mg in 1 1

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