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PEPCID COMPLETE

NDA

CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE | N020958 | KENVUE BRANDS 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
Brigham and Women's Hospital, Inc. et al v. Perrigo Company et al 1:2013cv11640 1 patentANDA 77355famotidine, magnesium hydroxide, and calcium carbonate	D. Mass.	2013-07-09	Terminated 2016-12-19	—

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

15 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 800MG;10MG;165MG

RLD

0 patents0 exclusivities▴

TABLET, CHEWABLE;ORAL | Approved: Oct 16, 2000

No patent or exclusivity listings for this strength.