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FDA ANDA · ANDA205509

MORPHINE SULFATE

Sponsor: ANI PHARMS

APPLICATION
ANDA205509
TYPE
ANDA
ORIGINAL APPROVAL
2018-04-17
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

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

Approval history

2026-06-18REMS · Supplement 7AP
2024-10-31REMS · Supplement 6AP
2018-09-18REMS · Supplement 1AP
2018-04-17UNKNOWN · Original · standard — Letter ↗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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