Prochlorperazine

ANDA 40407, held by Able. Prochlorperazine.

As of Nov 13, 2026, ANDA 40407 (Prochlorperazine), held by Able, was first approved by FDA on Jul 11, 2001, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 11, 2001
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
Jul 11, 2001	Original application	Approved	None posted

Products

3 strengths and forms


Prochlorperazine2.5MG · suppository;rectal	Prochlorperazine	Discontinued
Prochlorperazine5MG · suppository;rectal	Prochlorperazine	Discontinued
Prochlorperazine25MG · suppository;rectal	Prochlorperazine	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Sep 5, 2002	Supplement 1Labeling	Approved	None posted
Jul 11, 2001	Original application	Approved	None posted

Identifiers

Application: ANDA 40407
Drugs@FDA: Overview at FDA
Company: Able Laboratories

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