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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 007409

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NDA 007409 describes BENTYL, which is a drug marketed by Forest Labs Inc 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. Forty-seven suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.

Summary for 007409

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Gastrointestinal Agents
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. 58914-012 58914-012-10 100 CAPSULE in 1 BOTTLE, PLASTIC (58914-012-10)
BENTYL dicyclomine hydrochloride CAPSULE;ORAL 007409 NDA Allergan, Inc. 58914-013 58914-013-10 100 TABLET in 1 BOTTLE, PLASTIC (58914-013-10)

Summary for product number 001

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

Summary for product number 003

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


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