Myidyl

ANDA 87963, held by Usl Pharma. Triprolidine Hydrochloride.

As of Nov 15, 2026, ANDA 87963 (Myidyl), held by Usl Pharma, was first approved by FDA on Jan 18, 1983, with 7 approved supplements and 0 published complete response letters.

First approved: Jan 18, 1983
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jan 18, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Myidyl1.25MG/5ML · syrup;oral	Triprolidine Hydrochloride	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Aug 12, 1987	Supplement 7Manufacturing	Approved	None posted
Aug 12, 1987	Supplement 10Manufacturing	Approved	None posted
Apr 8, 1987	Supplement 8Manufacturing	Approved	None posted
Apr 8, 1987	Supplement 9Manufacturing	Approved	None posted
Dec 28, 1984	Supplement 1Manufacturing	Approved	None posted
Nov 20, 1984	Supplement 3Manufacturing	Approved	None posted
Nov 20, 1984	Supplement 4Manufacturing	Approved	None posted
Jan 18, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 87963
Drugs@FDA: Overview at FDA
Company: USL Pharma

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