Details for New Drug Application (NDA): 008370

NDA 008370 describes BENTYL PRESERVATIVE FREE, which is a drug marketed by Abbvie and is included in one NDA. It is available from two suppliers. 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. Fifty-five suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.

Summary for 008370

Tradename:	BENTYL PRESERVATIVE FREE
Applicant:	Abbvie
Ingredient:	dicyclomine hydrochloride
Patents:	0

Pharmacology for NDA: 008370

Mechanism of Action

Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 008370

Muscarinic Antagonists

Parasympatholytics

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	A-S Medication Solutions	50090-4553	50090-4553-0	2 mL in 1 AMPULE (50090-4553-0)
BENTYL	dicyclomine hydrochloride	INJECTABLE;INJECTION	008370	NDA	Allergan, Inc.	58914-080	58914-080-52	5 AMPULE in 1 BOX (58914-080-52) / 2 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Oct 15, 1984	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Oct 15, 1984	TE:		RLD:	Yes

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