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HYDROMORPHONE HYDROCHLORIDE

NDA

HYDROMORPHONE HYDROCHLORIDE | N200403 | HOSPIRA INC

5 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 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

7 letters from Drugs@FDA

Date	Submission	Document
Dec 31, 2025	SUPPL -61	View Letter (PDF)
Dec 19, 2023	SUPPL -48	View Letter (PDF)
Oct 9, 2019	SUPPL -18	View Letter (PDF)
Dec 21, 2016	SUPPL -6	View Letter (PDF)
Jul 20, 2015	SUPPL -4	View Letter (PDF)
Dec 5, 2011	ORIG -1	View Letter (PDF)
Mar 2, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 1MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 1, 2011

No patent or exclusivity listings for this strength.

#002 — 2MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 1, 2011

#003 — 4MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 1, 2011

#004 — 0.5MG/0.5ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jun 13, 2022

#005 — 0.25MG/0.5ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Mar 3, 2023