APPLICATION
ANDA076444
TYPE
ANDA
ORIGINAL APPROVAL
2003-04-25
LATEST ACTION
2026-07-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HYDROMORPHONE HYDROCHLORIDEDiscontinued
HYDROMORPHONE HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION
Approval history
2026-07-29Labeling · Supplement 14 · standardAP
2026-07-29Labeling · Supplement 13 · standardAP
2020-07-20Labeling · Supplement 12 · standardAP
2020-07-20Labeling · Supplement 11 · standardAP
2015-02-18Labeling · Supplement 3AP
2011-02-03Labeling · Supplement 5AP
2010-08-27Labeling · Supplement 7AP
2003-04-25OriginalAP
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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