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US Department of Justice
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Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078830

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NDA 078830 describes SCOPOLAMINE, which is a drug marketed by Perrigo Pharms Co and is included in one NDA. It is available from one supplier. Additional details are available on the SCOPOLAMINE profile page.

The generic ingredient in SCOPOLAMINE is scopolamine. There are twenty-one drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the scopolamine profile page.
Summary for 078830
Tradename:SCOPOLAMINE
Applicant:Perrigo Pharms Co
Ingredient:scopolamine
Patents:0
Therapeutic Class:Antiemetics
Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078830
Mechanism of ActionCholinergic Antagonists
Suppliers and Packaging for NDA: 078830
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SCOPOLAMINE scopolamine FILM, EXTENDED RELEASE;TRANSDERMAL 078830 ANDA Perrigo New York Inc 45802-580 45802-580-62 24 POUCH in 1 CARTON (45802-580-62) > 1 PATCH, EXTENDED RELEASE in 1 POUCH
SCOPOLAMINE scopolamine FILM, EXTENDED RELEASE;TRANSDERMAL 078830 ANDA Perrigo New York Inc 45802-580 45802-580-01 1 PATCH, EXTENDED RELEASE in 1 POUCH (45802-580-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength1MG/72HR
Approval Date:Jan 30, 2015TE:ABRLD:No

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Accenture
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Argus Health
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