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PROPAFENONE HYDROCHLORIDE

ANDA

PROPAFENONE HYDROCHLORIDE | A202688 | WATSON LABORATORIES INC

3 strengths0 unique patents0 unique exclusivities

API Supply Chain7 active DMFs4 inactive

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

PHARMAZELL GMBHPROPAFENONE HYDROCHLORIDE

DMF 106411993

PROCOS SPAPROPAFENONE HYDROCHLORIDE

DMF 114261995

ERREGIERRE SPAPROPAFENONE HYDROCHLORIDE USP-EP

DMF 130101998

SCI PHARMTECH INCPROPAFENONE HYDROCHLORIDE

DMF 235372010

ZYDUS LIFESCIENCES LTDPROPAFENONE HYDROCHLORIDE USP

DMF 250552011

EMCURE PHARMACEUTICALS LTDPROPAFENONE HYDROCHLORIDE USP

DMF 255882012

CHANGZHOU RUIMING PHARMACEUTICAL CO LTDPROPAFENONE HYDROCHLORIDE

DMF 379642023

ORGAMOL SAInactivePROPAFENONE HYDROCHLORIDE

DMF 83111989

SIEGFRIED CHEMIE AG LTDInactivePROPAFENONE HYDROCHLORIDE

DMF 126911997

CAMBREX PROFARMACO MILANO SRLInactivePROPAFENONE HYDROCHLORIDE

DMF 149852000

MYLAN LABORATORIES LTDInactivePROPAFENONE HYDROCHLORIDE USP

DMF 204182007

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 28, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 225MG

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Aug 24, 2015

No patent or exclusivity listings for this strength.

#002 — 325MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Aug 24, 2015

#003 — 425MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Aug 24, 2015