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FDA ANDA · ANDA211452

MORPHINE SULFATE

Sponsor: HIKMA

APPLICATION
ANDA211452
TYPE
ANDA
ORIGINAL APPROVAL
2023-01-12
LATEST ACTION
2023-01-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MORPHINE SULFATEPrescription
MORPHINE SULFATE 15MG/ML · INJECTABLE · INJECTION
MORPHINE SULFATEPrescription
MORPHINE SULFATE 8MG/ML · INJECTABLE · INJECTION
MORPHINE SULFATEPrescription
MORPHINE SULFATE 2MG/ML · INJECTABLE · INJECTION
MORPHINE SULFATEPrescription
MORPHINE SULFATE 10MG/ML · INJECTABLE · INJECTION
MORPHINE SULFATEPrescription
MORPHINE SULFATE 4MG/ML · INJECTABLE · INJECTION

Approval history

2023-01-12UNKNOWN · 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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