Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205861
Company: MACLEODS PHARMS LTD

Products on NDA 205861

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205861

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/14/2014	ORIG-1	Tentative Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205861Orig1s000TAltr.pdf