Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205508
Company: EMCURE PHARMS LTD

Products on NDA 205508

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATAZANAVIR SULFATE; RITONAVIR	ATAZANAVIR SULFATE; RITONAVIR	300MG; 100MG	TABLET; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205508

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/2014	ORIG-1	Tentative Approval	Type 4 - New Combination	PRIORITY	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205508Orig1s000TAltr.pdf