Details for New Drug Application (NDA): 017744

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NDA 017744 describes MOTOFEN HALF-STRENGTH, which is a drug marketed by Sebela Ireland Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the MOTOFEN HALF-STRENGTH profile page.

The generic ingredient in MOTOFEN HALF-STRENGTH is atropine sulfate; difenoxin hydrochloride. There are twenty-three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the atropine sulfate; difenoxin hydrochloride profile page.

Summary for 017744

Tradename:	MOTOFEN HALF-STRENGTH
Applicant:	Sebela Ireland Ltd
Ingredient:	atropine sulfate; difenoxin hydrochloride
Patents:	0

Pharmacology for NDA: 017744

Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 017744

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MOTOFEN	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744	NDA	Sebela Pharmaceuticals Inc.	54766-200	54766-200-04	4 TABLET in 1 BLISTER PACK (54766-200-04)
MOTOFEN	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744	NDA	Sebela Pharmaceuticals Inc.	54766-200	54766-200-10	100 TABLET in 1 BOTTLE (54766-200-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.025MG;0.5MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.025MG;1MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 017744

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	MOTOFEN	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Sebela Ireland Ltd	MOTOFEN HALF-STRENGTH	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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