Disipal

NDA 10653, held by 3m. Orphenadrine Hydrochloride.

As of Nov 14, 2026, NDA 10653 (Disipal), held by 3m, was first approved by FDA on May 10, 1957, with 3 approved supplements and 0 published complete response letters.

First approved: May 10, 1957
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
May 10, 1957	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Disipal50MG · tablet;oral	Orphenadrine Hydrochloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Apr 28, 1980	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 29, 1977	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 22, 1975	Supplement 9Manufacturing · Standard review	Approved	None posted
May 10, 1957	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 10653
Drugs@FDA: Overview at FDA
Company: 3M

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