Pemoline

ANDA 75286, held by Fosun Pharma. Pemoline.

As of Nov 13, 2026, ANDA 75286 (Pemoline), held by Fosun Pharma, was first approved by FDA on Jun 30, 1999, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 30, 1999
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 30, 1999	Original application	Approved	Letter

Products

3 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 20, 2002	Supplement 3Manufacturing	Approved	None posted
Dec 20, 2002	Supplement 4Manufacturing	Approved	None posted
Dec 27, 1999	Supplement 1Manufacturing	Approved	None posted
Dec 27, 1999	Supplement 2Labeling	Approved	None posted
Jun 30, 1999	Original application	Approved	Letter

Identifiers

Application: ANDA 75286
Drugs@FDA: Overview at FDA
Company: Fosun Pharma

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