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Serving leading biopharmaceutical companies globally:

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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076709

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NDA 076709 describes FENTANYL-75, which is a drug marketed by 3m Drug Delivery, Actavis Labs Ut Inc, Aveva, Lavipharm Labs, Mallinckrodt Inc, Mayne Pharma, Mylan Technologies, and Noven, and is included in eight NDAs. It is available from eighteen suppliers. Additional details are available on the FENTANYL-75 profile page.

The generic ingredient in FENTANYL-75 is fentanyl. There are thirty-one drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
Summary for 076709
Tradename:FENTANYL-75
Applicant:Actavis Labs Ut Inc
Ingredient:fentanyl
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 076709
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 076709
Suppliers and Packaging for NDA: 076709
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENTANYL-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 076709 ANDA Actavis Pharma, Inc. 0591-3198 0591-3198-72 5 POUCH in 1 CARTON (0591-3198-72) > 1 PATCH in 1 POUCH (0591-3198-54) > 72 h in 1 PATCH
FENTANYL-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 076709 ANDA Actavis Pharma, Inc. 0591-3212 0591-3212-72 5 POUCH in 1 CARTON (0591-3212-72) > 1 PATCH in 1 POUCH (0591-3212-54) > 72 h in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength25MCG/HR
Approval Date:Aug 20, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength50MCG/HR
Approval Date:Aug 20, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength75MCG/HR
Approval Date:Aug 20, 2007TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Queensland Health
Dow
UBS
Mallinckrodt
Healthtrust
Argus Health
Accenture
Citi
Moodys

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