APPLICATION
ANDA074653
TYPE
ANDA
ORIGINAL APPROVAL
1998-07-29
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL
Approval history
2026-06-18REMS · Supplement 21AP
2024-10-31REMS · Supplement 17AP
2020-04-10Labeling · Supplement 11 · standardAP
2020-04-10Labeling · Supplement 14 · standardAP
2018-09-18REMS · Supplement 9AP
1999-10-18Manufacturing (CMC) · Supplement 2AP
1999-05-11Manufacturing (CMC) · Supplement 1AP
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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