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FDA Approval

Adefovir dipivoxil

CompanyApotex Corp. (DUNS: 845263701)

Effective Date

December 1, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Adefovir dipivoxil(10 mg in 1 1)

Registrants (1)

DUNS Number

209429182

Products (1)

Adefovir dipivoxil

NDC Product Code

60505-3947

Application Number

ANDA205459

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 1, 2023

Ingredients

Adefovir dipivoxilActive

Code: U6Q8Z01514Class: ACTIBQuantity: 10 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

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