Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 206042
Company: MYLAN LABS LTD

Products on NDA 206042

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMTRICITABINE;TENOFOVIR DISOPROXIL FUMARATE;NEVIRAPINE	EMTRICITABINE;TENOFOVIR DISOPROXIL FUMARATE;NEVIRAPINE	200MG;300MG;200MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206042

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/12/2014	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/2014/206042Orig1s000TAltr.pdf