Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090561
Company: CIPLA

Products on ANDA 090561

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 090561

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/27/2010	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090561s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/17/2025	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
02/07/2020	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
02/07/2020	SUPPL-12	Labeling-Patient Package Insert		Label is not available on this site.
02/07/2020	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
02/07/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
02/07/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
10/25/2012	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090561

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