Oxybutynin Chloride

ANDA 74997, held by Pharm Assoc. Oxybutynin Chloride.

As of Nov 15, 2026, ANDA 74997 (Oxybutynin Chloride), held by Pharm Assoc, was first approved by FDA on Oct 15, 1997, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 15, 1997
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 15, 1997	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxybutynin Chloride5MG/5ML · syrup;oral	Oxybutynin Chloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jan 11, 2001	Supplement 2Manufacturing	Approved	None posted
Oct 27, 2000	Supplement 1Manufacturing	Approved	None posted
Oct 15, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74997
Drugs@FDA: Overview at FDA
Company: Pharmaceutical Associates

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