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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208252
Company: WATSON LABS INC

REMS

Products on ANDA 208252

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208252

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
02/17/2026	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/04/2025	SUPPL-7	REMS - MODIFIED - D-N-A		Label is not available on this site.
08/19/2024	SUPPL-5	REMS - MODIFIED - D-N-A		Label is not available on this site.
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-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208252

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
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	208354	SIGMAPHARM LABS LLC
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
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	208354	SIGMAPHARM LABS LLC
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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