Efidac 24 Chlorpheniramine Maleate

NDA 19746, held by Alza. Chlorpheniramine Maleate.

As of Nov 14, 2026, NDA 19746 (Efidac 24 Chlorpheniramine Maleate), held by Alza, was first approved by FDA on Nov 18, 1994, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 18, 1994
Review: Standard
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
Nov 18, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Efidac 24 Chlorpheniramine Maleate16MG · tablet, extended release;oral	Chlorpheniramine Maleate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Aug 6, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 18, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19746
Drugs@FDA: Overview at FDA
Company: ALZA

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