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FELODIPINE

ANDA

FELODIPINE | A203032 | ORBION PHARMACEUTICALS PRIVATE LTD

3 strengths0 unique patents0 unique exclusivities

API Supply Chain6 active DMFs10 inactive

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

CIPLA LTDFELODIPINE USP

DMF 114491995

MEDICHEM SAFELODIPINE

DMF 140991999

EVERLIGHT CHEMICAL INDUSTRIAL CORPFELODIPINE

DMF 170302003

APITORIA PHARMA PRIVATE LTDFELODIPINE USP, NON-STERILE DRUG SUBSTANCE

DMF 208902007

ORBION PHARMACEUTICALS PRIVATE LTDFELODIPINE (NON-STERILE BULK API)

DMF 213542008

ALEMBIC PHARMACEUTICALS LTDFELODIPINE USP

DMF 253732011

ESTEVE QUIMICA SAInactiveFELODIPINE

DMF 122481996

WOCKHARDT LTDInactiveFELODIPINE

DMF 132551998

YANGZHOU PHARMACEUTICAL FACTORYInactiveFELODIPINE

DMF 147862000

PCASInactiveFELODIPINE

DMF 185102005

YANGZHOU PHARMACEUTICAL CO LTDInactiveFelodipine USP

DMF 210512007

KOREA UNITED PHARMACEUTICALS INCInactiveFELODIPINE

DMF 216642008

HAINAN POLY PHARMACEUTICAL CO LTDInactiveFELODIPINE EXTENDED RELEASE TABLETS

DMF 237242010

EMCURE PHARMACEUTICALS LTDInactiveFELODIPINE USP

DMF 246812011

CHANGZHOU RUIMING PHARMACEUTICAL CO LTDInactiveFELODIPINE

DMF 254052011

HEC PHARM USA INCInactiveFELODIPINE NON-STERILE BULK DRUG SUBSTANCE

DMF 268112013

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 26, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 2.5MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: May 21, 2015

No patent or exclusivity listings for this strength.

#002 — 5MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 21, 2015

#003 — 10MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 21, 2015