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Details for New Drug Application (NDA): 008370

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NDA 008370 describes BENTYL PRESERVATIVE FREE, which is a drug marketed by Forest Labs Inc and is included in one NDA. It is available from one supplier. Additional details are available on the BENTYL PRESERVATIVE FREE profile page.

The generic ingredient in BENTYL PRESERVATIVE FREE is dicyclomine hydrochloride. There are four drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.

Summary for NDA: 008370

Tradename:
BENTYL
Applicant:
Forest Labs Inc
Ingredient:
dicyclomine hydrochloride
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 008370

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 008370

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENTYL
dicyclomine hydrochloride
INJECTABLE;INJECTION 008370 NDA Aptalis Pharma US, Inc. 58914-080 58914-080-52 5 AMPULE in 1 BOX (58914-080-52) > 2 mL in 1 AMPULE
BENTYL PRESERVATIVE FREE
dicyclomine hydrochloride
INJECTABLE;INJECTION 008370 NDA Aptalis Pharma US, Inc. 58914-080 58914-080-52 5 AMPULE in 1 BOX (58914-080-52) > 2 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Oct 15, 1984TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Oct 15, 1984TE:APRLD:Yes


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