APPLICATION
ANDA206573
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-14
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
MORPHINE SULFATEPrescription
MORPHINE SULFATE 10MG/5ML · SOLUTION · ORAL
MORPHINE SULFATEPrescription
MORPHINE SULFATE 100MG/5ML · SOLUTION · ORAL
Approval history
2026-06-18REMS · Supplement 19AP
2024-10-31REMS · Supplement 13AP
2023-05-08Labeling · Supplement 8 · standardAP
2023-05-08Labeling · Supplement 6 · standardAP
2023-05-08Labeling · Supplement 4 · standardAP
2023-05-08Labeling · Supplement 2 · standardAP
2023-05-08Labeling · Supplement 10 · standardAP
2018-09-18REMS · 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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