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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210715
Company: CIPLA

REMS

Products on ANDA 210715

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 210715

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/08/2021	SUPPL-6	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/22/2020	SUPPL-4	REMS - MODIFIED - D-N-A		Label is not available on this site.
02/14/2020	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/20/2020	SUPPL-2	REMS - MODIFIED - D-N-A		Label is not available on this site.
11/06/2019	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210715

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	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
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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