Drugs@FDA: FDA-Approved Drugs

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

Products on ANDA 205459

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205459

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-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205459

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
HEPSERA	ADEFOVIR DIPIVOXIL	10MG	TABLET;ORAL	Prescription	Yes	AB	021449	GILEAD