Pemoline

ANDA 75555, held by Teva Pharms. Pemoline.

As of Nov 13, 2026, ANDA 75555 (Pemoline), held by Teva Pharms, was first approved by FDA on Feb 18, 2000, with 6 approved supplements and 0 published complete response letters.

First approved: Feb 18, 2000
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Feb 18, 2000	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pemoline37.5MG · tablet, chewable;oral	Pemoline	Discontinued

All 7 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 10, 2001	Supplement 4Manufacturing	Approved	None posted
Oct 10, 2001	Supplement 5Manufacturing	Approved	None posted
Oct 10, 2001	Supplement 6Manufacturing	Approved	None posted
Dec 7, 2000	Supplement 1Manufacturing	Approved	None posted
Dec 7, 2000	Supplement 2Manufacturing	Approved	None posted
Dec 7, 2000	Supplement 3Manufacturing	Approved	None posted
Feb 18, 2000	Original application	Approved	Letter

Identifiers

Application: ANDA 75555
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals

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