CARVEDILOL

Manufacturing Establishments (1)

Rubicon Research Private Limited

Labeler

Advagen Pharma Ltd

DUNS Number

677604197

Products (4)

NDC Product Code

72888-034

Application Number

ANDA078165

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 17, 2021

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive

Code: T4V6TWG28DClass: IACT

POLYETHYLENE GLYCOL 800Inactive

Code: UH6KR4953DClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CarvedilolActive

Code: 0K47UL67F2Class: ACTIBQuantity: 3.125 mg in 1 1

CARVEDILOL

NDC Product Code

72888-036

Application Number

ANDA078165

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 17, 2021

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive

Code: T4V6TWG28DClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CarvedilolActive

Code: 0K47UL67F2Class: ACTIBQuantity: 12.5 mg in 1 1

POLYETHYLENE GLYCOL 800Inactive

Code: UH6KR4953DClass: IACT

CARVEDILOL

NDC Product Code

72888-035

Application Number

ANDA078165

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 17, 2021

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL 800Inactive

Code: UH6KR4953DClass: IACT

CarvedilolActive

Code: 0K47UL67F2Class: ACTIBQuantity: 6.25 mg in 1 1

HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive

Code: T4V6TWG28DClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CARVEDILOL

NDC Product Code

72888-037

Application Number

ANDA078165

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 17, 2021

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive

Code: T4V6TWG28DClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 800Inactive

Code: UH6KR4953DClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CarvedilolActive

Code: 0K47UL67F2Class: ACTIBQuantity: 25 mg in 1 1

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CARVEDILOL

Manufacturing Establishments (1)

Products (4)

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CARVEDILOL