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FDA ANDA · ANDA211454

MORPHINE SULFATE

Sponsor: WINDER LABS LLC

APPLICATION
ANDA211454
TYPE
ANDA
ORIGINAL APPROVAL
2021-02-12
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

MORPHINE SULFATEPrescription
MORPHINE SULFATE 20MG/5ML · SOLUTION · ORAL
MORPHINE SULFATEPrescription
MORPHINE SULFATE 100MG/5ML · SOLUTION · ORAL
MORPHINE SULFATEPrescription
MORPHINE SULFATE 10MG/5ML · SOLUTION · ORAL

Approval history

2026-06-18REMS · Supplement 4AP
2025-04-30REMS · Supplement 3AP
2022-02-16Labeling · Supplement 1 · standardAP
2021-02-12UNKNOWN · Original · standard — REMS ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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