Viewing data from:

SEMPREX-D

NDA

ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE | N019806 | ENDO OPERATIONS LTD

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Pharmobedient Consulting, LLC FDA-2025-P-1028 Pharmobedient Consulting, LLC filed a citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether the Reference Listed Drug SEMPREX-D (acrivastine; pseudoephedrine hydrochloride) capsule, 8 mg; 60 mg, under NDA 019806 was withdrawn from	505(q)	2025-04-02	Withdrawn	Pharmobedient Consulting

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 12, 2018	SUPPL -13	View Letter (PDF)
Feb 27, 2004	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 8MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Mar 25, 1994

No patent or exclusivity listings for this strength.