Morphine Sulfate

ANDA 200812, held by Strides Pharma Intl. Morphine Sulfate.

As of Nov 15, 2026, ANDA 200812 (Morphine Sulfate), held by Strides Pharma Intl, was first approved by FDA on Nov 10, 2011, with 14 approved supplements and 0 published complete response letters.

First approved: Nov 10, 2011
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Nov 10, 2011	Original application	Approved	Other Review

Products

6 strengths and forms


Morphine Sulfate20MG · capsule, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate30MG · capsule, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate50MG · capsule, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate60MG · capsule, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate80MG · capsule, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate100MG · capsule, extended release;oral	Morphine Sulfate	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 18REMS	Approved	None posted
Dec 22, 2025	Supplement 17Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 16REMS	Approved	None posted
Dec 15, 2023	Supplement 15Labeling · Standard review	Approved	None posted
Dec 1, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Dec 1, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 13REMS	Approved	None posted
May 26, 2017	Supplement 11REMS	Approved	None posted
Sep 30, 2016	Supplement 10REMS	Approved	None posted
Apr 20, 2016	Supplement 8REMS	Approved	None posted
Jun 26, 2015	Supplement 6REMS	Approved	None posted
Feb 6, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Aug 19, 2014	Supplement 5REMS	Approved	None posted
Apr 24, 2013	Supplement 2Labeling	Approved	None posted
Nov 10, 2011	Original application	Approved	Other Review

Identifiers

Application: ANDA 200812
Drugs@FDA: Overview at FDA
Company: Strides Pharma International

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