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HYDROMORPHONE HYDROCHLORIDE

ANDA

HYDROMORPHONE HYDROCHLORIDE | A202144 | ACTAVIS LABORATORIES FL INC

4 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
MALLINCKRODT INC. et al v. WATSON LABORATORIES, INC.-FLORIDA. et al 1:2012cv06744 1 patentANDA 202144Hydromorphone Hydrochloride Extended-Release	D.N.J.	2012-10-25	Terminated 2013-02-19	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain3 active DMFs6 inactive

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

NORAMCO LLCHYDROMORPHONE HYDROCHLORIDE DRUG SUBSTANCE

DMF 195612006

SIEGFRIED USA LLCHYDROMORPHONE HYDROCHLORIDE USP

DMF 220822008

SPECGX LLCHYDROMORPHONE HYDROCHLORIDE USP (NP)

DMF 257662012

DIOSYNTH BVInactiveHYDROMORPHONE HYDROCHLORIDE

DMF 70111987

TAKEDA PHARMACEUTICAL CO LTDInactiveHYDROMORPHONE HYDROCHLORIDE

DMF 70711987

SPECGX LLCInactiveHYDROMORPHONE HYDROCHLORIDE

DMF 72371987

NORAMCO LLCInactiveHYDROMORPHONE HYDROCHLORIDE USP

DMF 163512002

CODY LABORATORIES INCInactiveHYDROMORPHONE HYDROCHLORIDE USP

DMF 288042014

NORAMCO LLCInactiveHYDROMORPHONE HYDROCHLORIDE USP

DMF 319942020

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 1, 2016	SUPPL -6	View Letter (PDF)
May 13, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 8MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: May 12, 2014

No patent or exclusivity listings for this strength.

#002 — 12MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 12, 2014

#003 — 16MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 12, 2014

#004 — 32MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 30, 2016