Viewing data from:

AMBRISENTAN

ANDA

AMBRISENTAN | A210784 | SUN PHARMACEUTICAL INDUSTRIES LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: LETAIRIS

API Supply Chain9 active DMFs1 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

MATRIX PHARMACORP PRIVATE LTDAMBRISENTAN

DMF 245052010

MSN LABORATORIES PRIVATE LTDAMBRISENTAN [ROUTE CODE - AB]

DMF 261562012

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDAMBRISENTAN

DMF 275052013

MEDICHEM MANUFACTURING (MALTA) LTDAMBRISENTAN (MED-200028/M)

DMF 287812014

CIPLA LTDAMBRISENTAN

DMF 294902015

MEGAFINE PHARMA P LTDAMBRISENTAN

DMF 297922015

JIANGSU JOYGLORY PHARMACEUTICAL CO LTDAMBRISENTAN

DMF 307992016

TIANJIN WEIJIE PHARMACEUTICAL CO LTDAMBRISENTAN

DMF 311332016

SUN PHARMACEUTICAL INDUSTRIES LTDAMBRISENTAN

DMF 361052021

WATSON PHARMA PRIVATE LTDInactiveAMBRISENTAN

DMF 251342011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 1, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 28, 2019

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 28, 2019

Change History (2)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

Sun Pharmaceutical's Ambrisentan (NDA 210784) transitioned from prescription (RX) to discontinued (DISCN) status.

Old: RX

New: DISCN

MODIFIEDTE Code7/1/2026

Sun Pharmaceutical's Ambrisentan (NDA 210784) therapeutic equivalence code changed from AB to a different rating, affecting generic substitution eligibility.

Old: AB