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CLONIDINE HYDROCHLORIDE

ANDA

CLONIDINE HYDROCHLORIDE | A202984 | PH HEALTH LTD

2 strengths0 unique patents0 unique exclusivities

API Supply Chain5 active DMFs6 inactive

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

PCASCLONIDINE HYDROCHLORIDE

DMF 47781983

UNICHEM LABORATORIES LTDCLONIDINE HYDROCHLORIDE USP

DMF 169292003

ALEMBIC PHARMACEUTICALS LTDCLONIDINE HYDROCHLORIDE USP

DMF 223622008

YUNG ZIP CHEMICAL IND CO LTDCLONIDINE HYDROCHLORIDE

DMF 239062010

ENALTEC LABS PRIVATE LTDCLONIDINE HYDROCHLORIDE USP

DMF 313862017

LUSOCHIMICA SPAInactiveCLONIDINE HYDROCHLORIDE

DMF 59981985

ORCHIMIE SAInactiveCLONIDINE HYDROCHLORIDE

DMF 60141985

YUNG ZIP CHEMICAL INDUSTRY COMPANY LTDInactiveCLONIDINE HYDROCHLORIDE

DMF 61281985

DAIWA PHARMACEUTICAL CO LTDInactiveCLONIDINE HYDROCHLORIDE

DMF 63071986

UNICHEM LABORATORIES LTDInactiveCLONIDINE HYDROCHLORIDE

DMF 63571986

KV PHARMACEUTICAL COInactiveCLONIDINE HYDROCHLORIDE CONTROLLED RELEASE CAPSULES 0.2 MG.

DMF 76311988

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 1, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.1MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 30, 2013

No patent or exclusivity listings for this strength.

#002 — 0.2MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 30, 2013