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Serving hundreds of leading biopharmaceutical companies globally:

Teva
QuintilesIMS
Dow
Citi
Merck
Fish and Richardson
Deloitte
Chinese Patent Office
UBS

Generated: May 23, 2018

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
Tradename:MOTOFEN HALF-STRENGTH
Applicant:Sebela Ireland Ltd
Ingredient:atropine sulfate; difenoxin hydrochloride
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
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 N 54766-200-04
MOTOFEN atropine sulfate; difenoxin hydrochloride TABLET;ORAL 017744 NDA Sebela Pharmaceuticals Inc. 54766-200 N 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 atropine sulfate; difenoxin hydrochloride TABLET;ORAL 017744-002 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Sebela Ireland Ltd MOTOFEN HALF-STRENGTH atropine sulfate; difenoxin hydrochloride TABLET;ORAL 017744-001 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
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UBS
Harvard Business School
Chubb
Teva
Johnson and Johnson
Federal Trade Commission
Mallinckrodt

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