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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

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition Amendment from Rising Pharma Holdings, Inc. FDA-2024-P-5783 Rising Pharma Holdings, Inc. filed an amendment to its suitability petition FDA-2024-P-5783, originally submitted December 13, 2024, seeking permission to file an ANDA for Dicyclomine Hydrochloride Capsules USP in 20 mg and 40 mg strengths. The amendment provides the reference listed drug product la	Suitability	2025-01-10	Granted	—
Attachment 2 re Suitability Petition from Hyman, Phelps & McNamara PC FDA-2021-P-0074 Hyman, Phelps & McNamara PC filed this suitability petition regarding BENTYL (dicyclomine hydrochloride), an antispasmodic anticholinergic agent indicated for functional bowel and irritable bowel syndrome available in capsule, tablet, and intramuscular injection formulations. The petition requests F	Suitability	2021-01-26	Granted	Hyman, Phelps & McNamara PC
Attachment 3 re Suitability Petition from Hyman, Phelps & McNamara PC FDA-2021-P-0074 The document provided is prescribing information for dicyclomine hydrochloride tablets and does not contain details identifying who filed a citizen petition, what specific action was requested, or the petition's regulatory mechanism. The material consists of FDA-approved labeling highlights and full	Suitability	2021-01-26	Granted	Hyman, Phelps & McNamara PC

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

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.