Get our Free Patent Expiration, Litigation, and Drug Price Updates

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
US Army

Generated: May 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 007409

« Back to Dashboard

NDA 007409 describes BENTYL, which is a drug marketed by Allergan Sales Llc and Aptalis Pharma Us and is included in three NDAs. It is available from one supplier. Additional details are available on the BENTYL profile page.

The generic ingredient in BENTYL is dicyclomine hydrochloride. There are four drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.
Summary for 007409
Applicant:Allergan Sales Llc
Ingredient:dicyclomine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 007409
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 007409
Suppliers and Packaging for NDA: 007409
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENTYL dicyclomine hydrochloride CAPSULE;ORAL 007409 NDA Allergan, Inc. 58914-013 58914-013-10 100 TABLET in 1 BOTTLE, PLASTIC (58914-013-10)
BENTYL dicyclomine hydrochloride TABLET;ORAL 007409 NDA Allergan, Inc. 58914-013 58914-013-10 100 TABLET in 1 BOTTLE, PLASTIC (58914-013-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Oct 15, 1984TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Oct 15, 1984TE:ABRLD:Yes

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Army
Farmers Insurance
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.