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ADVIL PM

NDA

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN | N021393 | HALEON US HOLDINGS 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

9 letters from Drugs@FDA

Date	Submission	Document
Sep 10, 2024	SUPPL -22	View Letter (PDF)
Jan 12, 2022	SUPPL -21	View Letter (PDF)
May 10, 2018	SUPPL -17	View Letter (PDF)
Apr 3, 2017	SUPPL -14	View Letter (PDF)
Mar 21, 2013	SUPPL -12	View Letter (PDF)
Apr 21, 2011	SUPPL -7	View Letter (PDF)
May 27, 2009	SUPPL -6	View Letter (PDF)
Jun 16, 2008	SUPPL -5	View Letter (PDF)
Jan 19, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 21, 2005

No patent or exclusivity listings for this strength.