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FDA Approval

ADEFOVIR DIPIVOXIL

CompanySigmapharm Laboratories, LLC (DUNS: 556234636)

Effective Date

March 24, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Adefovir dipivoxil(10 mg in 1 1)

Registrants (1)

Sigmapharm Laboratories, LLC

DUNS Number

556234636

Manufacturing Establishments (1)

Sigmapharm Laboratories, LLC

Labeler

Sigmapharm Laboratories, LLC

Registrant

Sigmapharm Laboratories, LLC

DUNS Number

556234636

Products (1)

ADEFOVIR DIPIVOXIL

NDC Product Code

42794-003

Application Number

ANDA202051

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 24, 2023

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Adefovir dipivoxilActive

Code: U6Q8Z01514Class: ACTIBQuantity: 10 mg in 1 1

COPOVIDONEInactive

Code: D9C330MD8BClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

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