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HALFLYTELY

NDA

BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | N021551 | BRAINTREE LABORATORIES INC

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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Perrigo Company - Citizen Petition FDA-2010-P-0507 · 9 docket documents Perrigo Company filed this citizen petition under 21 C.F.R. §§ 10.25, 10.30, 314.122, and 314.161 requesting that the FDA determine whether HalfLytely® & Bisacodyl Tablets Bowel Prep Kit (containing two 5 mg bisacodyl delayed-release tablets), approved under NDA No. 21-551/S-006, was withdrawn for r	505(q)	2010-09-29	Granted	—
Foley & Lardner LLP - Citizen Petition FDA-2008-P-0412 · 6 docket documents Foley & Lardner LLP filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether HalfLytely and Bisacodyl Tablets Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and	505(q)	2008-07-18	Denied	—

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

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of the Efficacy and Safety of Quiklean® and Klean-Prep With Dulcolax® for the Bowel Preparation Prior to Colonoscopy NCT03992365	Phase 3	Completed	Universal Integrated Corp.	472	2019-06-10 → 2020-01-15

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jul 12, 2011	SUPPL -16	View Letter (PDF)
Jul 23, 2010	SUPPL -13	View Letter (PDF)
Sep 26, 2007	SUPPL -6	View Letter (PDF)
May 21, 2006	SUPPL -5	View Letter (PDF)
Mar 3, 2005	SUPPL -3	View Letter (PDF)
May 26, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#003 — 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL | Approved: Jul 16, 2010

No patent or exclusivity listings for this strength.