Meperidine Hydrochloride

ANDA 40352, held by Specgx LLC. Meperidine Hydrochloride.

As of Nov 15, 2026, ANDA 40352 (Meperidine Hydrochloride), held by Specgx LLC, was first approved by FDA on Jun 13, 2000, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 13, 2000
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
Jun 13, 2000	Original application	Approved	REMS Label Review Letter

Products

2 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Dec 15, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 5REMS	Approved	None posted
Nov 3, 2005	Supplement 4Labeling	Approved	None posted
Jun 13, 2000	Original application	Approved	REMS Label Review Letter

Identifiers

Application: ANDA 40352
Drugs@FDA: Overview at FDA
Company: SpecGx

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