U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204806
Company: AUROBINDO PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 100MG BASE CAPSULE;ORAL Prescription AB No No
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE;ORAL Prescription AB No No
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE;ORAL Prescription AB No No
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE;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
06/25/2018 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204806Orig1s000TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/26/2025 SUPPL-13 Labeling-Package Insert

Label is not available on this site.
06/21/2024 SUPPL-12 Labeling-Package Insert, Labeling

Label is not available on this site.
06/21/2024 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

ATAZANAVIR SULFATE

CAPSULE;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 204806 AUROBINDO PHARMA
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 091673 TEVA PHARMS USA

CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 204806 AUROBINDO PHARMA
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 212278 HETERO LABS LTD III
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 212579 LAURUS
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 091673 TEVA PHARMS USA

CAPSULE;ORAL; EQ 200MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE;ORAL Prescription No AB 204806 AUROBINDO PHARMA
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE;ORAL Prescription No AB 212278 HETERO LABS LTD III
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE;ORAL Prescription No AB 212579 LAURUS
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE;ORAL Prescription No AB 091673 TEVA PHARMS USA
REYATAZ ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE;ORAL Prescription Yes AB 021567 BRISTOL MYERS SQUIBB

CAPSULE;ORAL; EQ 300MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 204806 AUROBINDO PHARMA
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 212278 HETERO LABS LTD III
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 212579 LAURUS
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 091673 TEVA PHARMS USA
REYATAZ ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE;ORAL Prescription Yes AB 021567 BRISTOL MYERS SQUIBB
Back to Top