Meperidine Hydrochloride

ANDA 88282, held by Baxter Hlthcare. Meperidine Hydrochloride.

As of Nov 15, 2026, ANDA 88282 (Meperidine Hydrochloride), held by Baxter Hlthcare, was first approved by FDA on Jun 15, 1984, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 15, 1984
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jun 15, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Meperidine Hydrochloride100MG/ML · injectable;injection	Meperidine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Nov 3, 1986	Supplement 1Manufacturing	Approved	None posted
Jun 15, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88282
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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