Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205355
Company: HETERO LABS LTD III

Products on NDA 205355

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205355

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/14/2014	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/2014/205355Orig1s000ltr.pdf