Methadone Hydrochloride

ANDA 208305, held by Sun Pharm Industries. Methadone Hydrochloride.

As of Nov 15, 2026, ANDA 208305 (Methadone Hydrochloride), held by Sun Pharm Industries, was first approved by FDA on Mar 30, 2018, with 8 approved supplements and 0 published complete response letters.

First approved: Mar 30, 2018
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Mar 30, 2018	Original application	Approved	REMS Letter

Products

2 strengths and forms


Methadone Hydrochloride5MG · tablet;oral	Methadone Hydrochloride	Discontinued
Methadone Hydrochloride10MG · tablet;oral	Methadone Hydrochloride	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 10REMS	Approved	None posted
Dec 22, 2025	Supplement 7Labeling · Standard review	Approved	None posted
Dec 22, 2025	Supplement 9Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 8REMS	Approved	None posted
Dec 15, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Jun 2, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Feb 18, 2021	Supplement 4Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 2REMS	Approved	None posted
Mar 30, 2018	Original application	Approved	REMS Letter

Identifiers

Application: ANDA 208305
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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