Serpasil-Apresoline

NDA 9296, held by Novartis. Hydralazine Hydrochloride; Reserpine.

As of Nov 13, 2026, NDA 9296 (Serpasil-Apresoline), held by Novartis, was first approved by FDA on Apr 1, 1954, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 1, 1954
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Apr 1, 1954	Original applicationNew combination · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Serpasil-Apresoline50MG;0.2MG · tablet;oral	Hydralazine Hydrochloride; Reserpine	Discontinued
Serpasil-Apresoline25MG;0.1MG · tablet;oral	Hydralazine Hydrochloride; Reserpine	Discontinued

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 8, 1987	Supplement 22Labeling	Approved	None posted
May 8, 1987	Supplement 23Labeling	Approved	None posted
Aug 26, 1985	Supplement 18Labeling	Approved	None posted
Jul 20, 1983	Supplement 19Labeling	Approved	None posted
Oct 31, 1979	Supplement 14Labeling	Approved	None posted
Apr 1, 1954	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 9296
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