Meperidine Hydrochloride

ANDA 40446, held by Sun Pharm Inds Inc. Meperidine Hydrochloride.

As of Nov 15, 2026, ANDA 40446 (Meperidine Hydrochloride), held by Sun Pharm Inds Inc, was first approved by FDA on Aug 8, 2002, with 10 approved supplements and 0 published complete response letters.

First approved: Aug 8, 2002
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Aug 8, 2002	Original application	Approved	Review REMS Letter

Products

2 strengths and forms


Meperidine Hydrochloride50MG · tablet;oral	Meperidine Hydrochloride	Discontinued
Meperidine Hydrochloride100MG · tablet;oral	Meperidine Hydrochloride	Discontinued

All 11 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
May 13, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Dec 13, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 11REMS	Approved	None posted
Jun 23, 2009	Supplement 7Labeling	Approved	None posted
Sep 12, 2006	Supplement 1Labeling	Approved	None posted
Aug 8, 2002	Original application	Approved	Review REMS Letter

Identifiers

Application: ANDA 40446
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