Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202051
Company: SIGMAPHARM LABS LLC

Products on ANDA 202051

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202051

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/2013	ORIG-1	Approval	Not Applicable		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202051Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202051Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/26/2020	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Labels for ANDA 202051

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/29/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202051Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 202051

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