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HYDROMORPHONE HYDROCHLORIDE

ANDA

HYDROMORPHONE HYDROCHLORIDE | A216899 | HIKMA PHARMACEUTICALS USA INC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: DILAUDID(TE code: AP)

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

1 letter from Drugs@FDA

Date	Submission	Document
Mar 7, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

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#001 — 0.2MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Feb 9, 2024

No patent or exclusivity listings for this strength.

#002 — 0.5MG/0.5ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Feb 9, 2024

#003 — 1MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Feb 9, 2024

#004 — 2MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Feb 9, 2024