Morphine Sulfate

ANDA 202309, held by Chartwell Molecular. Morphine Sulfate.

As of Nov 15, 2026, ANDA 202309 (Morphine Sulfate), held by Chartwell Molecular, was first approved by FDA on Nov 25, 2015, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 25, 2015
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 25, 2015	Original application	Approved	REMS Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Morphine Sulfate10MG/5ML · solution;oral	Morphine Sulfate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Sep 18, 2018	Supplement 2REMS · Standard review	Approved	None posted
Nov 25, 2015	Original application	Approved	REMS Label Letter

Identifiers

Application: ANDA 202309
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters