Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021971
Company: CIPLA LIMITED
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE 150MG; 300MG; 200MG TABLET; ORAL None (Tentative Approval) None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/31/2007 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/2007/021971s000TAltr.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English