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Generated: July 21, 2017

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 Actavis Labs Ut Inc, Aveva, Lavipharm Labs, Mallinckrodt Inc, Mylan Technologies, Mayne Pharma, Noven, and 3m Drug Delivery, and is included in eight NDAs. It is available from nineteen 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-three suppliers are listed for this compound. Additional details are available on the fentanyl profile page.

Summary for NDA: 076709

Tradename:
4
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 076709

Mechanism of ActionFull Opioid Agonists

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

Summary for product number 001

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

Summary for product number 002

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

Summary 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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