Propantheline Bromide

ANDA 80927, held by Hikma. Propantheline Bromide.

As of Nov 15, 2026, ANDA 80927 (Propantheline Bromide), held by Hikma, was first approved by FDA on Sep 9, 1974, with 13 approved supplements and 0 published complete response letters.

First approved: Sep 9, 1974
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Sep 9, 1974	Original application	Approved	None posted

Products

2 strengths and forms


Propantheline Bromide7.5MG · tablet;oral	Propantheline Bromide	Discontinued
Propantheline Bromide15MG · tablet;oral	Propantheline Bromide	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Feb 7, 2000	Supplement 39Manufacturing	Approved	None posted
Mar 12, 1999	Supplement 38Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 37Manufacturing	Approved	None posted
Feb 27, 1992	Supplement 35Manufacturing	Approved	None posted
Feb 27, 1992	Supplement 36Manufacturing	Approved	None posted
Oct 4, 1991	Supplement 29Manufacturing	Approved	None posted
Oct 4, 1991	Supplement 30Manufacturing	Approved	None posted
Oct 4, 1991	Supplement 31Manufacturing	Approved	None posted
Jun 20, 1991	Supplement 34Labeling	Approved	None posted
Mar 18, 1991	Supplement 33Labeling	Approved	None posted
Nov 13, 1989	Supplement 28Labeling	Approved	None posted
Sep 11, 1989	Supplement 27Manufacturing	Approved	None posted
Feb 25, 1986	Supplement 25Manufacturing	Approved	None posted
Sep 9, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 80927
Drugs@FDA: Overview at FDA
Company: Hikma

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