Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 203041
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600MG;200MG;300MG TABLET;ORAL Prescription AB 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
09/04/2018 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203041Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203041Orig1s000Ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/27/2020 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL; 600MG;200MG;300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATRIPLA EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600MG;200MG;300MG TABLET;ORAL Prescription Yes AB 021937 GILEAD SCIENCES
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600MG;200MG;300MG TABLET;ORAL Prescription No AB 203041 AUROBINDO PHARMA LTD
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600MG;200MG;300MG TABLET;ORAL Prescription No AB 206894 CIPLA

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