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BENTYL

NDA

DICYCLOMINE HYDROCHLORIDE | N007961 | APTALIS PHARMA US 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

API Supply Chain4 active DMFs2 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

OLON SPADICYCLOMINE HYDROCHLORIDE

DMF 23031974

INDOCO REMEDIES LTDDICYCLOMINE HYDROCHLORIDE USP

DMF 222952008

HONOUR LAB LTDDICYCLOMINE HYDROCHLORIDE

DMF 369772022

AMI LIFESCIENCES PRIVATE LTDDICYCLOMINE HYDROCHLORIDE

DMF 400782024

NORISTAN LTDInactiveDICYCLOMINE HYDROCHLORIDE

DMF 94581991

PCASInactiveDICYCLOMINE HYDROCHLORIDE

DMF 104601993

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 2, 2011	SUPPL -28	View Letter (PDF)
Feb 12, 2007	SUPPL -26	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Oct 15, 1984

No patent or exclusivity listings for this strength.