Semprex-D

NDA 19806, held by Endo Operations. Acrivastine; Pseudoephedrine Hydrochloride.

As of Nov 13, 2026, NDA 19806 (Semprex-D), held by Endo Operations, was first approved by FDA on Mar 25, 1994, with 7 approved supplements and 0 published complete response letters.

First approved: Mar 25, 1994
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
Mar 25, 1994	Original applicationNew molecular entity, new combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Semprex-D8MG;60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Acrivastine; Pseudoephedrine Hydrochloride	DiscontinuedReference drug

All 8 submissions, including labeling and manufacturing supplements


Apr 11, 2018	Supplement 13Labeling · Standard review	Approved	Letter Label
Feb 25, 2004	Supplement 8Labeling · Standard review	Approved	Letter
Feb 20, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 21, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 4, 1997	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 30, 1996	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 23, 1994	Supplement 1Labeling · Standard review	Approved	None posted
Mar 25, 1994	Original applicationNew molecular entity, new combination · Standard review	Approved	None posted

Identifiers

Application: NDA 19806
Drugs@FDA: Overview at FDA
Company: Endo Operations

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