Drugs@FDA: FDA Approved Drug Products

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

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

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 LTD
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 200626 CIPLA
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 LTD
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 200626 CIPLA
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 208177 MYLAN PHARMS INC
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 091673 TEVA PHARMS USA
REYATAZ ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE;ORAL Prescription Yes AB 021567 BRISTOL MYERS SQUIBB

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 LTD
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE;ORAL Prescription No AB 200626 CIPLA
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE;ORAL Prescription No AB 208177 MYLAN PHARMS INC
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 LTD
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 200626 CIPLA
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 208177 MYLAN PHARMS INC
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

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