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REPAGLINIDE

ANDA

REPAGLINIDE | A091517 | KENTON CHEMICALS AND PHARMACEUTICALS CORP

3 strengths0 unique patents0 unique exclusivities

API Supply Chain11 active DMFs5 inactive

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

DR REDDYS LABORATORIES LTDREPAGLINIDE

DMF 172452004

SUN PHARMACEUTICAL INDUSTRIES LTDREPAGLINIDE USP

DMF 178252004

USV PRIVATE LTDREPAGLINIDE USP

DMF 183292005

BIOCON LTDREPAGLINIDE

DMF 184822005

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGREPAGLINIDE

DMF 196202006

MACLEODS PHARMACEUTICALS LTDREPAGLINIDE

DMF 222342008

APITORIA PHARMA PRIVATE LTDREPAGLINIDE USP (NON-STERILE DRUG SUBSTANCE)

DMF 230682009

JUBILANT PHARMOVA LTDREPAGLINIDE USP

DMF 245192011

TORRENT PHARMACEUTICALS LTDREPAGLINIDE

DMF 256632012

CHROMO LABORATORIES INDIA PRIVATE LTDREPAGLINIDE USP

DMF 263962012

TIANJIN PHARMACEUTICAL HOLDINGS GENCOM PHARMACY CO LTDREPAGLINIDE

DMF 299222015

CHEMWERTH INCInactiveREPAGLINIDE USP

DMF 180032005

RANBAXY LABORATORIES LTDInactiveREPAGLINIDE USP

DMF 190102005

ZHEJIANG HISOAR PHARMACEUTICAL CO LTDInactiveREPAGLINIDE

DMF 209992007

ZAKLADY FARMACEUTYCZNE POLPHARMA SAInactiveREPAGLINIDE

DMF 211492007

ASYMCHEM LIFE SCIENCE TIANJIN CO LTDInactiveREPAGLINIDE

DMF 288382014

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 27, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 24, 2015

No patent or exclusivity listings for this strength.

#002 — 1MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 24, 2015

#003 — 2MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 24, 2015