Biphetamine 20, Biphetamine 12.5, Biphetamine 7.5

NDA 10093, held by Ucb Inc. Amphetamine Resin Complex; Dextroamphetamine Resin Complex.

As of Nov 13, 2026, NDA 10093 (Biphetamine 20, Biphetamine 12.5, Biphetamine 7.5), held by Ucb Inc, was first approved by FDA on Sep 9, 1955, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 9, 1955
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 9, 1955	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Biphetamine 20EQ 10MG BASE;EQ 10MG BASE · capsule, extended release;oral	Amphetamine Resin Complex; Dextroamphetamine Resin Complex	Discontinued
Biphetamine 12.5EQ 6.25MG BASE;EQ 6.25MG BASE · capsule, extended release;oral	Amphetamine Resin Complex; Dextroamphetamine Resin Complex	Discontinued
Biphetamine 7.5EQ 3.75MG BASE;EQ 3.75MG BASE · capsule, extended release;oral	Amphetamine Resin Complex; Dextroamphetamine Resin Complex	Discontinued

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 16, 1983	Supplement 13Manufacturing · Standard review	Approved	None posted
May 6, 1983	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 4, 1979	Supplement 11Labeling · Standard review	Approved	None posted
Sep 9, 1955	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 10093
Drugs@FDA: Overview at FDA
Company: UCB

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