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FDA NDA · NDA201517

MORPHINE SULFATE

Sponsor: CHARTWELL MOLECULAR

APPLICATION
NDA201517
TYPE
NDA
ORIGINAL APPROVAL
2011-06-23
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

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

Approval history

2025-12-22Labeling · Supplement 19 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 18 · standard — Label ↗AP
2021-03-04Labeling · Supplement 17 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 15 · standard — Label ↗AP
2018-09-18Labeling · Supplement 13 · standard — Label ↗AP
2018-09-18REMS · Supplement 12 — Label ↗AP
2017-01-09Manufacturing (CMC) · Supplement 7 · standardAP
2016-12-16Labeling · Supplement 9 · standard — Label ↗AP
2016-02-22Manufacturing (CMC) · Supplement 8 · standardAP
2013-07-10Manufacturing (CMC) · Supplement 5 · standardAP
2011-06-23Type 3 - New Dosage Form · Original · standard — Review ↗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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