Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200732
Company: MYLAN LABS LTD

Products on NDA 200732

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZIDOVUDINE	ZIDOVUDINE	100MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200732

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/23/2011	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200732s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200732s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200732_zidovudine_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/27/2019	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200732s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/200732Orig1s002ltr.pdf
11/08/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 200732

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/27/2019	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200732s002lbl.pdf
02/23/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200732s000lbl.pdf