Pemoline

ANDA 75030, held by Teva Pharms. Pemoline.

As of Nov 13, 2026, ANDA 75030 (Pemoline), held by Teva Pharms, was first approved by FDA on Jan 29, 1999, with 10 approved supplements and 0 published complete response letters.

First approved: Jan 29, 1999
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
Jan 29, 1999	Original application	Approved	Letter

Products

3 strengths and forms

Product	Active ingredient	Marketing
Pemoline37.5MG · tablet;oral	Pemoline	Discontinued
Pemoline75MG · tablet;oral	Pemoline	Discontinued
Pemoline18.75MG · tablet;oral	Pemoline	Discontinued

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 7, 2000	Supplement 13Manufacturing	Approved	None posted
Dec 7, 2000	Supplement 12Manufacturing	Approved	None posted
Dec 7, 2000	Supplement 11Manufacturing	Approved	None posted
Feb 22, 2000	Supplement 10Labeling	Approved	None posted
Feb 22, 2000	Supplement 9Manufacturing	Approved	None posted
Feb 22, 2000	Supplement 8Manufacturing	Approved	None posted
Aug 13, 1999	Supplement 7Labeling	Approved	None posted
Jun 11, 1999	Supplement 6Manufacturing	Approved	None posted
Jun 11, 1999	Supplement 5Manufacturing	Approved	None posted
Jun 11, 1999	Supplement 1Manufacturing	Approved	None posted
Jan 29, 1999	Original application	Approved	Letter

Identifiers

Application: ANDA 75030
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