APPLICATION
ANDA078261
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-14
LATEST ACTION
2025-04-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION
Approval history
2025-04-24Labeling · Supplement 12 · standardAP
2020-05-20Labeling · Supplement 7 · standardAP
2020-05-20Labeling · Supplement 4 · standardAP
2015-02-04Labeling · Supplement 2 · standardAP
2010-04-14OriginalAP
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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