Viewing data from:

CLARITIN-D

NDA

LORATADINE; PSEUDOEPHEDRINE SULFATE | N019670 | 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Nov 14, 2023	SUPPL -36	View Letter (PDF)
Aug 3, 2018	SUPPL -34	View Letter (PDF)
Nov 27, 2015	SUPPL -32	View Letter (PDF)
Feb 17, 2010	SUPPL -22	View Letter (PDF)
Apr 27, 2009	SUPPL -20	View Letter (PDF)
Aug 2, 2004	SUPPL -19	View Letter (PDF)
Nov 27, 2002	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — 5MG;120MG

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Nov 27, 2002

No patent or exclusivity listings for this strength.