Morphine Sulfate

ANDA 201011, held by Sankalp Lifecare. Morphine Sulfate.

As of Nov 15, 2026, ANDA 201011 (Morphine Sulfate), held by Sankalp Lifecare, was first approved by FDA on Feb 5, 2014, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 5, 2014
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
Feb 5, 2014	Original application	Approved	REMS

Products

3 strengths and forms


Morphine Sulfate10MG/5ML · solution;oral	Morphine Sulfate	Discontinued
Morphine Sulfate20MG/5ML · solution;oral	Morphine Sulfate	Discontinued
Morphine Sulfate100MG/5ML · solution;oral	Morphine Sulfate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 4REMS	Approved	None posted
Oct 31, 2024	Supplement 2REMS	Approved	None posted
Sep 18, 2018	Supplement 1REMS	Approved	None posted
Feb 5, 2014	Original application	Approved	REMS

Identifiers

Application: ANDA 201011
Drugs@FDA: Overview at FDA
Company: Sankalp Lifecare

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