Propantheline Bromide

ANDA 83029, held by Watson Labs. Propantheline Bromide.

As of Nov 15, 2026, ANDA 83029 (Propantheline Bromide), held by Watson Labs, was first approved by FDA on Jan 15, 1975, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 15, 1975
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 15, 1975	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Apr 25, 1988	Supplement 47Labeling	Approved	None posted
Jan 15, 1975	Original application	Approved	None posted

Identifiers

Application: ANDA 83029
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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