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ANAGRELIDE HYDROCHLORIDE

ANDA

ANAGRELIDE HYDROCHLORIDE | A076489 | ROXANE LABORATORIES INC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain8 active DMFs2 inactive

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

ASH STEVENS INCANAGRELIDE HYDROCHLORIDE MONOHYDRATE

DMF 159712002

CIPLA LTDANAGRELIDE HYDROCHLORIDE MONOHYDRATE USP

DMF 160242002

CHEMWERTH INCANAGRELIDE HYDROCHLORIDE MONOHYDRATE

DMF 164402003

ZYDUS LIFESCIENCES LTDANAGRELIDE HYDROCHLORIDE USP

DMF 165312003

OLPHA ASANAGRELIDE HYDROCHLORIDE

DMF 170412003

TORRENT PHARMACEUTICALS LTDANAGRELIDE HYDROCHLORIDE USP

DMF 294752015

MICRO LABS LTDANAGRELIDE HYDROCHLORIDE USP

DMF 371802022

PIRAMAL PHARMA LTDANAGRELIDE HYDROCHLORIDE MONOHYDRATE

DMF 381812023

AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPAInactiveANAGRELIDE HYDROCHLORIDE

DMF 169692003

CHEMISCH PHARMAZEUTISCHES LABOR ROLF SACHSE GMBHInactiveANAGRELIDE HYDROCHLORIDE

DMF 182402005

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 28, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 0.5MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Apr 18, 2005

No patent or exclusivity listings for this strength.

#002 — EQ 1MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Apr 18, 2005