Morphine Sulfate

Manages pain severe enough to require an opioid analgesic. ANDA 202348, held by Specgx LLC. Morphine Sulfate.

As of Nov 15, 2026, ANDA 202348 (Morphine Sulfate), held by Specgx LLC, was first approved by FDA on Jul 15, 2011, with 8 approved supplements and 0 published complete response letters.

First approved: Jul 15, 2011
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant adult patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including morphine sulfate oral solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jul 15, 2011	Original application	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Morphine Sulfate100MG/5ML · solution;oral	Morphine Sulfate	Rx

All 9 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 20REMS	Approved	None posted
Oct 31, 2024	Supplement 16REMS	Approved	None posted
Feb 24, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Feb 24, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Feb 24, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 6REMS	Approved	None posted
Oct 31, 2016	Supplement 3Labeling · Standard review	Approved	None posted
May 4, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Jul 15, 2011	Original application	Approved	REMS

Identifiers

Application: ANDA 202348
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