Morphine Sulfate

ANDA 205386, held by Dr Reddys Labs SA. Morphine Sulfate.

As of Nov 15, 2026, ANDA 205386 (Morphine Sulfate), held by Dr Reddys Labs SA, was first approved by FDA on Oct 28, 2016, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 28, 2016
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 28, 2016	Original application	Approved	REMS

Products

4 strengths and forms


Morphine Sulfate15MG · tablet, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate30MG · tablet, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate60MG · tablet, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate100MG · tablet, extended release;oral	Morphine Sulfate	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Sep 18, 2018	Supplement 5REMS	Approved	None posted
May 26, 2017	Supplement 3REMS	Approved	None posted
Oct 28, 2016	Original application	Approved	REMS

Identifiers

Application: ANDA 205386
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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