Propantheline Bromide

ANDA 88377, held by Par Pharm. Propantheline Bromide.

As of Nov 15, 2026, ANDA 88377 (Propantheline Bromide), held by Par Pharm, was first approved by FDA on Oct 25, 1993, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 25, 1993
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
Oct 25, 1993	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Oct 25, 1993	Original application	Approved	None posted
Mar 20, 1991	Supplement 14Labeling	Approved	None posted
Aug 29, 1988	Supplement 11Labeling	Approved	None posted
Jun 16, 1988	Supplement 10Labeling	Approved	None posted

Identifiers

Application: ANDA 88377
Drugs@FDA: Overview at FDA
Company: Par Pharmaceutical

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