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Last Updated: August 9, 2020

DrugPatentWatch Database Preview

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
Pharmacology for NDA: 017744
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:DISCNDosage:TABLET;ORALStrength0.025MG;0.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.025MG;1MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 017744

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

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