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OLMESARTAN MEDOXOMIL

ANDA

OLMESARTAN MEDOXOMIL | A206763 | ALKEM LABORATORIES LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: BENICAR(TE code: AB)

API Supply Chain29 active DMFs13 inactive

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

MATRIX PHARMACORP PRIVATE LTDOLMESARTAN MEDOXOMIL USP

DMF 204172007

TAPI NL BVOLMESARTAN MEDOXOMIL USP

DMF 219312008

CADILA PHARMACEUTICALS LTDOLMESARTAN MEDOXOMIL USP

DMF 228612009

CHIERON ACTIVE INGREDIENTS PRIVATE LIMITEDOLMESARTAN MEDOXOMIL

DMF 231532009

MSN LABORATORIES PRIVATE LTDOLMESARTAN MEDOXOMIL USP [ROUTE CODE OX]

DMF 236902010

TORRENT PHARMACEUTICALS LTDOLMESARTAN MEDOXOMIL USP

DMF 241802010

ZYDUS LIFESCIENCES LTDOLMESARTAN MEDOXOMIL USP

DMF 246442011

ALEMBIC PHARMACEUTICALS LTDOLMESARTAN MEDOXOMIL USP

DMF 246712011

ULKAR KIMYA SANAYII VE TICARET ASOLMESARTAN MEDOXOMIL USP

DMF 258602012

APITORIA PHARMA PRIVATE LTDOLMESARTAN MEDOXOMIL USP

DMF 260352012

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDOLMESARTAN MEDOXOMIL USP

DMF 261432012

MACLEODS PHARMACEUTICALS LTDOLMESARTAN MEDOXOMIL

DMF 263182012

JUBILANT PHARMOVA LTDOLMESARTAN MEDOXOMIL USP

DMF 269292013

HETERO LABS LTDOLMESARTAN MEDOXOMIL

DMF 269922013

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)OLMESARTAN MEDOXOMIL USP

DMF 271642013

MICRO LABS LTDOLMESARTAN MEDOXOMIL USP

DMF 275392013

DIVIS LABORATORIES LTDOLMESARTAN MEDOXOMIL USP

DMF 279502014

EUROAPI HUNGARY LTDOLMESARTAN MEDOXOMIL USP

DMF 284442014

SHANDONG ANXIN PHARMACEUTICAL CO LTDOLMESARTAN MEDOXOMIL USP (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 296402015

HEC PHARM CO LTDOLMESARTAN MEDOXOMIL NON-STERILE BULK DRUG SUSTANCE

DMF 301712016

ZHEJIANG TIANYU PHARMACEUTICAL CO LTDOLMESARTAN MEDOXOMIL

DMF 318882018

CHROMO LABORATORIES INDIA PRIVATE LTDOLMESARTAN MEDOXOMIL USP

DMF 335872019

ZHUHAI RUNDU PHARMACEUTICAL CO LTDOLMESARTAN MEDOXOMIL

DMF 349412020

MOREPEN LABORATORIES LTDOLMESARTAN MEDOXOMIL

DMF 365552021

GRANULES INDIA LTDOLMESARTAN MEDOXOMIL USP

DMF 368652022

VASUDHA PHARMA CHEM LTDOLMESARTAN MEDOXOMIL USP

DMF 380152023

VIYASH LIFE SCIENCES PRIVATE LTDOLMESARTAN MEDOXOMIL USP

DMF 385292024

CTX LIFESCIENCES PVT LTDOLMESARTAN MEDOXOMIL USP

DMF 398412024

APITORIA PHARMA PRIVATE LTDOLMESARTAN MEDOXOMIL USP (PROCESS-II)

DMF 408902025

DAIICHI SANKYO CO LTDInactiveOLMESARTAN MEDOXOMIL DRUG SUBSTANCE

DMF 149532000

DR REDDYS LABORATORIES LTDInactiveOLMESARTAN MEDOXOMIL

DMF 193842006

AMINO CHEMICALS LTDInactiveOLMESARTAN MEDOXOMIL

DMF 227212009

UNIMARK REMEDIES LTDInactiveOLMESARTAN MEDOXOMIL

DMF 236172010

DR REDDYS LABORATORIES LTDInactiveOLMESARTAN MEDOXOMIL USP (PROCESS II)

DMF 236582010

RANBAXY LABORATORIES LTDInactiveOLMESARTAN MEDOXOMIL

DMF 244322010

APOTEX PHARMACHEM INDIA PVT LTDInactiveOLMESARTAN MEDOXOMIL USP

DMF 254942011

CTX LIFE SCIENCES PVT LTDInactiveOLMESARTAN MEDOXOMIL

DMF 261982012

QILU TIANHE PHARMACEUTICAL CO LTDInactiveOLMESARTAN MEDOXOMIL (NON-STERILA API)

DMF 264202012

LUPIN LTDInactiveOLMESARTAN MEDOXOMIL USP

DMF 267822013

UNICHEM LABORATORIES LTDInactiveOLMESARTAN MEDOXOMIL USP

DMF 290262015

VASUDHA PHARMA CHEM LTDInactiveOLMESARTAN MEDOXOMIL USP

DMF 291132015

HIKAL LTDInactiveOLMESARTAN MEDOXOMIL USP

DMF 304332016

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 26, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 24, 2017

No patent or exclusivity listings for this strength.

#002 — 20MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 24, 2017

#003 — 40MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 24, 2017