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DRIXORAL

NDA

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE | N013483 | SCHERING PLOUGH HEALTHCARE PRODUCTS INC

2 strengths0 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
Elite Laboratories, Inc - Citizen Petition FDA-2013-P-0694 · 3 docket documents Elite Laboratories, Inc. filed this citizen petition pursuant to 21 CFR 314.122 requesting that the FDA determine that the approved ANDA product dexbrompheniramine maleate 6mg/pseudoephedrine sulfate 120mg extended release (ANDA 078648, Avanthi Inc.) is suitable as a Reference Listed Drug because th	Other	2013-06-19	Withdrawn	—

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 11, 2005	SUPPL -42	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#004 — 6MG;120MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 13, 1982

#003 — 6MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 13, 1982

No patent or exclusivity listings for this strength.