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FDA Approval

Candesartan Cilexetil and Hydrochlorothiazide

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

FDA Approval Summary

Company

Mylan Pharmaceuticals Inc.

DUNS: 059295980

Effective Date

August 15, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Hydrochlorothiazide(25 mg in 1 1)

Candesartan(32 mg in 1 1)

Products3

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

Candesartan Cilexetil and Hydrochlorothiazide

Product Details

NDC Product Code

0378-3003

Application Number

ANDA090704

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 15, 2020

Ingredients

HydrochlorothiazideActive

Code: 0J48LPH2THClass: ACTIBQuantity: 25 mg in 1 1

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

CandesartanActive

Code: R85M2X0D68Class: ACTIBQuantity: 32 mg in 1 1

CARBOXYMETHYLCELLULOSE CALCIUMInactive

Code: UTY7PDF93LClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

Candesartan Cilexetil and Hydrochlorothiazide

Product Details

NDC Product Code

0378-3002

Application Number

ANDA090704

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 15, 2020

Ingredients

CandesartanActive

Code: R85M2X0D68Class: ACTIBQuantity: 32 mg in 1 1

HydrochlorothiazideActive

Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1

CARBOXYMETHYLCELLULOSE CALCIUMInactive

Code: UTY7PDF93LClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4Class: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

Candesartan Cilexetil and Hydrochlorothiazide

Product Details

NDC Product Code

0378-3001

Application Number

ANDA090704

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 15, 2020

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CARBOXYMETHYLCELLULOSE CALCIUMInactive

Code: UTY7PDF93LClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4Class: IACT

CandesartanActive

Code: R85M2X0D68Class: ACTIBQuantity: 16 mg in 1 1

HydrochlorothiazideActive

Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1

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