Paredrine

NDA 4, held by Pharmics. Hydroxyamphetamine Hydrobromide.

As of Nov 13, 2026, NDA 4 (Paredrine), held by Pharmics, was first approved by FDA on Jul 16, 1969, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 16, 1969
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
Jul 16, 1969	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Paredrine1% · solution/drops;ophthalmic	Hydroxyamphetamine Hydrobromide	Discontinued

All 3 submissions, including labeling and manufacturing supplements


May 26, 1987	Supplement 11Labeling	Approved	None posted
May 8, 1980	Supplement 10Labeling	Approved	None posted
Jul 16, 1969	Original application	Approved	None posted

Identifiers

Application: NDA 4
Drugs@FDA: Overview at FDA
Company: Pharmics

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