Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022464
Company: STRIDES ARCOLAB LTD

Products on NDA 022464

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE	LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE	150MG; 200MG; 300MG	TABLET; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022464

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2009	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/2009/022464s000ltr.pdf