Viewing data from:

CHLOR-TRIMETON

NDA

CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE | N018397 | BAYER HEALTHCARE LLC

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
The Weinberg Group Inc. - Citizen Petition FDA-2009-P-0478 · 3 docket documents The Weinberg Group Inc. submitted this suitability petition on October 1, 2009, requesting that the FDA declare chlorpheniramine maleate 8 mg and pseudoephedrine hydrochloride 120 mg extended-release capsules suitable for submission as an ANDA, with the reference listed drug being Chlor-Trimeton All	Other	2009-10-05	Withdrawn	—

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Products (1)

#001 — 8MG;120MG

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.