Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021969
Company: CIPLA LIMITED

Products on NDA 021969

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LAMIVUDINE; STAVUDINE; NEVIRAPINE	LAMIVUDINE; STAVUDINE; NEVIRAPINE	150MG; 30MG; 200MG	TABLET; ORAL	None (Tentative Approval)	None	No	No
LAMIVUDINE; STAVUDINE; NEVIRAPINE	LAMIVUDINE; STAVUDINE; NEVIRAPINE	150MG; 40MG; 200MG	TABLET; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021969

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/2006	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/2006/021969s000TAltr.pdf