Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 022346
Company: PHARMACARE LTD

Products on NDA 022346

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022346

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2009	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/2009/022346s000ltr.pdf