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VALSARTAN

ANDA

VALSARTAN | A201677 | LUPIN LTD

4 strengths0 unique patents0 unique exclusivities

API Supply Chain32 active DMFs17 inactive

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

MATRIX PHARMACORP PRIVATE LTDVALSARTAN USP

DMF 182532005

JUBILANT BIOSYS LTDVALSARTAN USP

DMF 189672005

LUPIN LTDVALSARTAN USP

DMF 193012006

DR REDDYS LABORATORIES LTDVALSARTAN

DMF 203192007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDVALSARTAN USP (PROCESS II)

DMF 234912010

ALEMBIC PHARMACEUTICALS LTDVALSARTAN USP (PROCESS II)

DMF 235842010

NOVARTIS PHARMACEUTICALS CORPVALSARTAN DRUG SUBSTANCE

DMF 239022010

MACLEODS PHARMACEUTICALS LTDVALSARTAN USP

DMF 241782010

APITORIA PHARMA PRIVATE LTDVALSARTAN USP (PROCESS II)

DMF 245442011

TAPI NL BVVALSARTAN

DMF 247242011

DIVIS LABORATORIES LTDVALSARTAN USP

DMF 247972011

SECOND PHARMA CO LTDVALSARTAN

DMF 258482012

CADILA PHARMACEUTICALS LTDVALSARTAN USP (PROCESS 2)

DMF 261672012

IPCA LABORATORIES LTDVALSARTAN USP

DMF 288242016

HETERO LABS LTDVALSARTAN (PROCESS-III)

DMF 293922015

MSN LIFE SCIENCES PRIVATE LTDVALSARTAN USP

DMF 315982018

ZHEJIANG TIANYU PHARMACEUTICAL CO LTDVALSARTAN

DMF 321752017

ZHUHAI RUNDU PHARMACEUTICAL CO LTDVALSARTAN

DMF 323282017

BIOCON LTDVALSARTAN DISODIUM

DMF 334272019

ZHUHAI RUNDU PHARMACEUTICAL CO LTDVALSARTAN DISODIUM

DMF 334712019

ZHEJIANG TIANYU PHARMACEUTICAL CO LTDVALSARTAN DISODIUM

DMF 334752018

SYNTHON BVVALSARTAN DISODIUM

DMF 336482019

HARMAN FINOCHEM LTDVALSARTAN USP

DMF 342872019

ZYDUS LIFESCIENCES LTDVALSARTAN USP

DMF 348262020

BIOPHORE INDIA PHARMACEUTICALS PVT LTDValsartan

DMF 355102020

MANKIND PHARMA LTDVALSARTAN DISODIUM

DMF 362032021

IOL CHEMICALS AND PHARMACEUTICALS LTDVALSARTAN USP

DMF 383392023

LAURUS LABS LTDVALSARTAN USP

DMF 384502023

CHANGZHOU PHARMACEUTICAL FACTORYVALSARTAN

DMF 410942025

LINHAI TIANYU PHARMACEUTICAL CO LTDVALSARTAN DISODIUM (PROCESS II)

DMF 416222025

CHANGZHOU PHARMACEUTICAL FACTORYVALSARTAN DISODIUM

DMF 420152025

LINHAI TIANYU PHARMACEUTICAL CO LTDVALSARTAN DISODIUM (PROCESS III)

DMF 425632025

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveVALSARTAN USP

DMF 178972004

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveVALSARTAN

DMF 179092004

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDInactiveVALSARTAN DRUG SUBSTANCE

DMF 209392007

ALEMBIC PHARMACEUTICALS LTDInactiveValsartan USP ( PROCESS I)

DMF 211342007

AUROBINDO PHARMA LTDInactiveVALSARTAN USP (NON-STERILE DRUG SUBSTANCE)

DMF 218452008

CADILA PHARMACEUTICALS LTDInactiveVALSARTAN

DMF 221832008

IPCA LABORATORIES LTDInactiveVALSARTAN USP

DMF 226142010

CADILA HEALTHCARE LTDInactiveVALSARTAN USP

DMF 226842009

SIGNA SA DE CVInactiveVALSARTAN USP

DMF 231502009

HETERO LABS LTDInactiveVALSARTAN

DMF 248732011

ZHUHAI RUNDU PHARMACEUTICAL CO LTDInactiveVALSARTAN

DMF 255102011

HETERO LABS LTDInactiveVALSARTAN (PROCESS II)

DMF 263972012

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveVALSARTAN USP

DMF 266902012

ALEMBIC PHARMACEUTICALS LTDInactiveVALSARTAN USP (PROCESS III)

DMF 277802013

NINGBO MENOVO PHARMACEUTICAL CO LTDInactiveVALSARTAN

DMF 332542018

CHROMO LABORATORIES INDIA PRIVATE LTDInactiveVALSARTAN USP

DMF 335862019

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveVALSARTAN USP

DMF 337702019

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

Products (4)

Sort:

#001 — 40MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 5, 2015

No patent or exclusivity listings for this strength.

#002 — 80MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 5, 2015

#003 — 160MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 5, 2015

#004 — 320MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 5, 2015

Change History (8)

Recent changes detected for this application.

MODIFIEDTE Code7/1/2026

Lupin's Valsartan (NDA 201677) therapeutic equivalence code changed from AB to a different classification.

Old: AB

MODIFIEDtype7/1/2026

Lupin's Valsartan (NDA 201677) transitioned from prescription to discontinued status.

Old: RX

New: DISCN

MODIFIEDtype7/1/2026

Lupin's Valsartan application (NDA 201677) transitioned from prescription to discontinued status.

Old: RX

New: DISCN

MODIFIEDTE Code7/1/2026

Lupin's Valsartan (NDA 201677, supplement 004) therapeutic equivalence code changed from AB to a different rating.

Old: AB

MODIFIEDTE Code7/1/2026

Lupin's valsartan (NDA 201677, supplement 003) therapeutic equivalence code changed from AB to a different rating.

Old: AB

MODIFIEDtype7/1/2026

Lupin's valsartan product (NDA 201677) transitioned from prescription (RX) to discontinued (DISCN) status.

Old: RX

New: DISCN

MODIFIEDTE Code7/1/2026

Lupin's Valsartan (NDA 201677) therapeutic equivalence code changed from AB, affecting generic substitutability classification for this angiotensin II receptor antagonist.

Old: AB

MODIFIEDtype7/1/2026

Lupin's Valsartan (NDA 201677, supplement 003) transitioned from prescription (RX) to discontinued (DISCN) status.

Old: RX

New: DISCN