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Abbreviated New Drug Application (ANDA): 208252
Company: WATSON LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMBRISENTAN AMBRISENTAN 5MG TABLET;ORAL Prescription AB No No
AMBRISENTAN AMBRISENTAN 10MG 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
03/28/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208252Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/08/2021 SUPPL-4 REMS - MODIFIED - D-N-A

Label is not available on this site.

12/22/2020 SUPPL-2 REMS - MODIFIED - D-N-A

Label is not available on this site.

11/29/2019 SUPPL-1 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

AMBRISENTAN

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMBRISENTAN AMBRISENTAN 5MG TABLET;ORAL Prescription No AB 210701 APOTEX
AMBRISENTAN AMBRISENTAN 5MG TABLET;ORAL Prescription No AB 216531 AUROBINDO PHARMA LTD
AMBRISENTAN AMBRISENTAN 5MG TABLET;ORAL Prescription No AB 210715 CIPLA
AMBRISENTAN AMBRISENTAN 5MG TABLET;ORAL Prescription No AB 208441 MYLAN
AMBRISENTAN AMBRISENTAN 5MG TABLET;ORAL Prescription No AB 209509 PAR PHARM INC
AMBRISENTAN AMBRISENTAN 5MG TABLET;ORAL Prescription No AB 208354 SIGMAPHARM LABS LLC
AMBRISENTAN AMBRISENTAN 5MG TABLET;ORAL Prescription No AB 210784 SUN PHARM
AMBRISENTAN AMBRISENTAN 5MG TABLET;ORAL Prescription No AB 208252 WATSON LABS INC
AMBRISENTAN AMBRISENTAN 5MG TABLET;ORAL Prescription No AB 210058 ZYDUS PHARMS
LETAIRIS AMBRISENTAN 5MG TABLET;ORAL Prescription Yes AB 022081 GILEAD

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMBRISENTAN AMBRISENTAN 10MG TABLET;ORAL Prescription No AB 210701 APOTEX
AMBRISENTAN AMBRISENTAN 10MG TABLET;ORAL Prescription No AB 216531 AUROBINDO PHARMA LTD
AMBRISENTAN AMBRISENTAN 10MG TABLET;ORAL Prescription No AB 210715 CIPLA
AMBRISENTAN AMBRISENTAN 10MG TABLET;ORAL Prescription No AB 208441 MYLAN
AMBRISENTAN AMBRISENTAN 10MG TABLET;ORAL Prescription No AB 209509 PAR PHARM INC
AMBRISENTAN AMBRISENTAN 10MG TABLET;ORAL Prescription No AB 208354 SIGMAPHARM LABS LLC
AMBRISENTAN AMBRISENTAN 10MG TABLET;ORAL Prescription No AB 210784 SUN PHARM
AMBRISENTAN AMBRISENTAN 10MG TABLET;ORAL Prescription No AB 208252 WATSON LABS INC
AMBRISENTAN AMBRISENTAN 10MG TABLET;ORAL Prescription No AB 210058 ZYDUS PHARMS
LETAIRIS AMBRISENTAN 10MG TABLET;ORAL Prescription Yes AB 022081 GILEAD
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