Morphine Sulfate

ANDA 202718, held by Teva Pharms USA. Morphine Sulfate.

As of Nov 15, 2026, ANDA 202718 (Morphine Sulfate), held by Teva Pharms USA, was first approved by FDA on Dec 29, 2014, with 14 approved supplements and 0 published complete response letters.

First approved: Dec 29, 2014
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
Dec 29, 2014	Original application	Approved	Other Letter

Products

8 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
Morphine Sulfate40MG · capsule, extended release;oral	Morphine Sulfate	Discontinued
Morphine Sulfate70MG · capsule, extended release;oral	Morphine Sulfate	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 16REMS	Approved	None posted
Dec 22, 2025	Supplement 15Labeling · Standard review	Approved	None posted
Oct 9, 2025	Supplement 13Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 14REMS	Approved	None posted
Dec 15, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Dec 4, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Dec 4, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 7REMS	Approved	None posted
May 26, 2017	Supplement 5REMS	Approved	None posted
Sep 30, 2016	Supplement 4REMS	Approved	None posted
Apr 20, 2016	Supplement 3REMS	Approved	None posted
Jun 26, 2015	Supplement 2REMS	Approved	None posted
Jun 3, 2015	Supplement 1Manufacturing	Approved	None posted
Dec 29, 2014	Original application	Approved	Other Letter

Identifiers

Application: ANDA 202718
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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