Propantheline Bromide

ANDA 80928, held by Sandoz. Propantheline Bromide.

As of Nov 15, 2026, ANDA 80928 (Propantheline Bromide), held by Sandoz, was not approved, with 5 approved supplements and 0 published complete response letters.

First approved: Not approved
Supplements approved: 5
Complete response letters: 0

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propantheline Bromide15MG · tablet;oral	Propantheline Bromide	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jun 1, 1984	Supplement 64Manufacturing	Approved	None posted
Dec 12, 1983	Supplement 47Manufacturing	Approved	None posted
Aug 1, 1983	Supplement 63Manufacturing	Approved	None posted
Aug 1, 1983	Supplement 62Manufacturing	Approved	None posted
Aug 1, 1983	Supplement 61Manufacturing	Approved	None posted

Identifiers

Application: ANDA 80928
Drugs@FDA: Overview at FDA
Company: Sandoz

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