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ENTACAPONE

ANDA

ENTACAPONE | A207210 | MACLEODS PHARMACEUTICALS LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: COMTAN(TE code: AB)

API Supply Chain14 active DMFs6 inactive

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

FERMION OYENTACAPONE

DMF 124441997

SUVEN PHARMACEUTICALS LTDENTACAPONE

DMF 190922006

WOCKHARDT LTDENTACAPONE USP

DMF 193852006

SUN PHARMACEUTICAL INDUSTRIES LTDENTACAPONE

DMF 203262007

NEULAND LABORATORIES LTDENTACAPONE USP (FORM-A)

DMF 215262008

DIPHARMA FRANCIS SRLENTACAPONE

DMF 225382009

COHANCE LIFESCIENCES LTDENTACAPONE USP

DMF 239372010

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

DMF 241882010

JUBILANT PHARMOVA LTDENTACAPONE

DMF 243612010

MACLEODS PHARMACEUTICALS LTDENTACAPONE

DMF 254102011

HETERO LABS LTDENTACAPONE

DMF 265012012

HEC PHARM CO LTDENTACAPONE NON-STERILE BULK DRUG SUBSTANCE

DMF 271092013

PIRAMAL PHARMA LTDENTACAPONE

DMF 290102015

SUVEN PHARMACEUTICALS LTDENTACAPONE USP

DMF 333302018

USV LTDInactiveENTACAPONE

DMF 221332008

ARCH PHARMALABS LTDInactiveENTACAPONE

DMF 227142009

RANBAXY LABORATORIES LTDInactiveENTACAPONE

DMF 234122009

STANDARD CHEM AND PHARM CO LTDInactiveENTACAPONE

DMF 238042010

ERREGIERRE SPAInactiveENTACAPONE

DMF 239332010

FIS FABBRICA ITALIANA SINTETICI SPAInactiveENTACAPONE

DMF 239842010

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 9, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 5, 2017

No patent or exclusivity listings for this strength.