Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078922
Company: MYLAN PHARMS INC

Products on ANDA 078922

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZIDOVUDINE	ZIDOVUDINE	300MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078922

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/14/2008	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078922s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/26/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
06/26/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
03/30/2012	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
03/02/2011	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078922

ZIDOVUDINE

TABLET;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ZIDOVUDINE	ZIDOVUDINE	300MG	TABLET;ORAL	Prescription	No	AB	077267	AUROBINDO
ZIDOVUDINE	ZIDOVUDINE	300MG	TABLET;ORAL	Prescription	No	AB	090561	CIPLA
ZIDOVUDINE	ZIDOVUDINE	300MG	TABLET;ORAL	Prescription	No	AB	090092	HETERO LABS LTD III
ZIDOVUDINE	ZIDOVUDINE	300MG	TABLET;ORAL	Prescription	No	AB	078922	MYLAN PHARMS INC