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DURACLON

NDA

CLONIDINE HYDROCHLORIDE | N020615 | MYLAN INSTITUTIONAL LLC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

2 letters from Drugs@FDA

Date	Submission	Document
Aug 2, 2010	SUPPL -3	View Letter (PDF)
May 4, 2009	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1MG/10ML (0.1MG/ML)

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 2, 1996

No patent or exclusivity listings for this strength.

#002 — 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Apr 27, 1999