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Generated: December 14, 2017

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-two 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:2
Applicant:1
Ingredient:1
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 54766-200-10 100 TABLET in 1 BOTTLE (54766-200-10)
MOTOFEN HALF-STRENGTH atropine sulfate; difenoxin hydrochloride TABLET;ORAL 017744 NDA Sebela Pharmaceuticals Inc. 54766-200 54766-200-10 100 TABLET in 1 BOTTLE (54766-200-10)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.025MG;0.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 002

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

Expired Orange Book Patents for NDA: 017744

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland LtdMOTOFEN HALF-STRENGTHatropine sulfate; difenoxin hydrochlorideTABLET;ORAL017744-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Sebela Ireland LtdMOTOFENatropine sulfate; difenoxin hydrochlorideTABLET;ORAL017744-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Merck
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