Morphine Sulfate

NDA 20631, held by Specgx LLC. Morphine Sulfate.

As of Nov 14, 2026, NDA 20631 (Morphine Sulfate), held by Specgx LLC, was first approved by FDA on Jul 3, 1996, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 3, 1996
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 3, 1996	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Morphine Sulfate1MG/ML · injectable;injection	Morphine Sulfate	Discontinued
Morphine Sulfate2MG/ML · injectable;injection	Morphine Sulfate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Dec 15, 2023	Supplement 3Labeling · Standard review	Approved	Letter Label
Oct 7, 2019	Supplement 2Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 1Labeling · Standard review	Approved	Label Letter
Jul 3, 1996	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 20631
Drugs@FDA: Overview at FDA
Company: SpecGx

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