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FDA NDA · NDA200403

HYDROMORPHONE HYDROCHLORIDE

Sponsor: HOSPIRA INC

APPLICATION
NDA200403
TYPE
NDA
ORIGINAL APPROVAL
2011-12-01
LATEST ACTION
2025-12-22
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 0.25MG/0.5ML · INJECTABLE · INJECTION
HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 4MG/ML · INJECTABLE · INJECTION
HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 1MG/ML · INJECTABLE · INJECTION
HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML · INJECTABLE · INJECTION
HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 2MG/ML · INJECTABLE · INJECTION

Approval history

2025-12-22Labeling · Supplement 61 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 48 · standard — Label ↗AP
2019-10-07Labeling · Supplement 18 · standard — Label ↗AP
2016-12-16Labeling · Supplement 6 · standard — Label ↗AP
2016-11-21Manufacturing (CMC) · Supplement 7 · standardAP
2015-09-03Manufacturing (CMC) · Supplement 5 · standardAP
2015-07-16Labeling · Supplement 4 · standard — Label ↗AP
2014-08-18Manufacturing (CMC) · Supplement 3 · standardAP
2013-06-11Manufacturing (CMC) · Supplement 1 · standardAP
2011-12-01Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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