U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078064
Company: AUROBINDO PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EFAVIRENZ EFAVIRENZ 50MG CAPSULE;ORAL Prescription AB No No
EFAVIRENZ EFAVIRENZ 100MG CAPSULE;ORAL Prescription None No No
EFAVIRENZ EFAVIRENZ 200MG CAPSULE;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/15/2017 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/078064Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/20/2024 SUPPL-17 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

02/04/2020 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

EFAVIRENZ

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFAVIRENZ EFAVIRENZ 50MG CAPSULE;ORAL Prescription No AB 078064 AUROBINDO PHARMA

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFAVIRENZ EFAVIRENZ 200MG CAPSULE;ORAL Prescription No AB 078064 AUROBINDO PHARMA
Back to Top