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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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