Regitine

NDA 8278, held by Novartis. Phentolamine Mesylate.

As of Nov 13, 2026, NDA 8278 (Regitine), held by Novartis, was first approved by FDA on Jan 30, 1952, with 15 approved supplements and 0 published complete response letters.

First approved: Jan 30, 1952
Review: Priority
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Jan 30, 1952	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Regitine5MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Phentolamine Mesylate	DiscontinuedReference drug

All 16 submissions, including labeling and manufacturing supplements


Apr 29, 1999	Supplement 20Manufacturing · Priority review	Approved	None posted
Feb 5, 1999	Supplement 19Manufacturing · Priority review	Approved	None posted
Nov 5, 1998	Supplement 18Manufacturing · Priority review	Approved	None posted
Oct 20, 1998	Supplement 17Manufacturing · Priority review	Approved	None posted
Jan 9, 1992	Supplement 16Manufacturing · Priority review	Approved	None posted
Apr 14, 1986	Supplement 15Manufacturing · Priority review	Approved	None posted
May 13, 1985	Supplement 11Labeling	Approved	None posted
Jul 27, 1983	Supplement 12Manufacturing · Priority review	Approved	None posted
Jul 21, 1983	Supplement 13Manufacturing · Priority review	Approved	None posted
Sep 9, 1981	Supplement 10Manufacturing · Priority review	Approved	None posted
Feb 18, 1981	Supplement 9Manufacturing · Priority review	Approved	None posted
Jan 7, 1980	Supplement 8Manufacturing · Priority review	Approved	None posted
Apr 12, 1977	Supplement 6Labeling	Approved	None posted
Feb 11, 1977	Supplement 7Manufacturing · Priority review	Approved	None posted
Feb 11, 1977	Supplement 5Manufacturing · Priority review	Approved	None posted
Jan 30, 1952	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 8278
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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