Valpin 50

NDA 13428, held by Endo Pharms. Anisotropine Methylbromide.

As of Nov 13, 2026, NDA 13428 (Valpin 50), held by Endo Pharms, was first approved by FDA on Nov 23, 1962, with 8 approved supplements and 0 published complete response letters.

First approved: Nov 23, 1962
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below


Sep 3, 1976	Supplement 21Efficacy (new indication or use) · Standard review	Approved	None posted
Nov 23, 1962	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Valpin 5050MG · tablet;oral	Anisotropine Methylbromide	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Jul 2, 1986	Supplement 31Labeling · Standard review	Approved	None posted
Sep 23, 1983	Supplement 30Manufacturing · Standard review	Approved	None posted
Jan 11, 1982	Supplement 29Manufacturing · Standard review	Approved	None posted
Jul 25, 1979	Supplement 27Manufacturing · Standard review	Approved	None posted
Oct 16, 1978	Supplement 26Manufacturing · Standard review	Approved	None posted
Apr 17, 1978	Supplement 24Labeling · Standard review	Approved	None posted
Feb 21, 1978	Supplement 25Manufacturing · Standard review	Approved	None posted
Sep 3, 1976	Supplement 21Efficacy (new indication or use) · Standard review	Approved	None posted
Nov 23, 1962	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 13428
Drugs@FDA: Overview at FDA
Company: Endo 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