Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206040
Company: MYLAN LABS LTD

Products on NDA 206040

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LAMIVUDINE; ZIDOVUDINE; EFAVIRENZ	LAMIVUDINE;ZIDOVUDINE;EFAVIRENZ	150MG;300MG;600MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206040

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/04/2014	ORIG-1	Tentative Approval	Type 4 - New Combination	STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206040Orig1s000TAltr.pdf