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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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Wyeth LLC et al v. Apotex Inc. et al 1:2017cv00168	D. Del.	2017-02-16	Terminated 2017-11-13	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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

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.