Hylorel

NDA 18104, held by Pharmacia And Upjohn. Guanadrel Sulfate.

As of Nov 13, 2026, NDA 18104 (Hylorel), held by Pharmacia And Upjohn, was first approved by FDA on Dec 29, 1982, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 29, 1982
Review: Standard
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
Dec 29, 1982	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms


Hylorel10MG · tablet;oral	Guanadrel Sulfate	Discontinued
Hylorel25MG · tablet;oral	Guanadrel Sulfate	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Aug 1, 1990	Supplement 6Labeling	Approved	None posted
Aug 1, 1990	Supplement 7Labeling	Approved	None posted
Oct 7, 1986	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 20, 1985	Supplement 3Labeling	Approved	None posted
Aug 20, 1985	Supplement 4Labeling	Approved	None posted
Sep 13, 1983	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 1, 1983	Supplement 1Labeling	Approved	None posted
Dec 29, 1982	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 18104
Drugs@FDA: Overview at FDA
Company: Pharmacia & Upjohn

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