← FDA DRUG APPROVALS

FDA ANDA · ANDA205758

MORPHINE SULFATE

Sponsor: HIKMA

APPLICATION
ANDA205758
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-21
LATEST ACTION
2015-05-21
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

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

Approval history

2015-05-21UNKNOWN · 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →