Oreticyl 25, Oreticyl Forte, Oreticyl 50

NDA 12148, held by Abbvie. Deserpidine; Hydrochlorothiazide.

As of Nov 13, 2026, NDA 12148 (Oreticyl 25, Oreticyl Forte, Oreticyl 50), held by Abbvie, was first approved by FDA on Dec 14, 1959, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 14, 1959
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 14, 1959	Original applicationNew combination · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Oreticyl 250.125MG;25MG · tablet;oral	Deserpidine; Hydrochlorothiazide	Discontinued
Oreticyl Forte0.25MG;25MG · tablet;oral	Deserpidine; Hydrochlorothiazide	Discontinued
Oreticyl 500.125MG;50MG · tablet;oral	Deserpidine; Hydrochlorothiazide	Discontinued

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 17, 2001	Supplement 6Labeling	Approved	None posted
Feb 16, 1994	Supplement 19Labeling	Approved	None posted
Feb 16, 1994	Supplement 18Labeling	Approved	None posted
Feb 16, 1994	Supplement 14Labeling	Approved	None posted
Feb 8, 1984	Supplement 16Labeling	Approved	None posted
Aug 20, 1979	Supplement 10Labeling	Approved	None posted
Aug 20, 1979	Supplement 8Labeling	Approved	None posted
Dec 14, 1959	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 12148
Drugs@FDA: Overview at FDA
Company: AbbVie

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