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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205459
Company: APOTEX

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADEFOVIR DIPIVOXIL ADEFOVIR DIPIVOXIL 10MG TABLET;ORAL Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/06/2018 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/12/2023 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

ADEFOVIR DIPIVOXIL

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADEFOVIR DIPIVOXIL ADEFOVIR DIPIVOXIL 10MG TABLET;ORAL Prescription No AB 205459 APOTEX
ADEFOVIR DIPIVOXIL ADEFOVIR DIPIVOXIL 10MG TABLET;ORAL Prescription No AB 202051 SIGMAPHARM LABS LLC
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