Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 202157
Company: HETERO LABS UNIT III
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/18/2011 ORIG-1 Tentative Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202157s000ltr.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