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Generated: January 20, 2019

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Details for New Drug Application (NDA): 076258

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NDA 076258 describes FENTANYL-87, which is a drug marketed by Aveva and Mylan Technologies and is included in two NDAs. It is available from seven suppliers. Additional details are available on the FENTANYL-87 profile page.

The generic ingredient in FENTANYL-87 is fentanyl. There are thirty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
Summary for 076258
Tradename:FENTANYL-87
Applicant:Mylan Technologies
Ingredient:fentanyl
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076258
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 076258
Suppliers and Packaging for NDA: 076258
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENTANYL-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 076258 ANDA Mylan Pharmaceuticals Inc. 0378-9119 0378-9119-98 5 POUCH in 1 CARTON (0378-9119-98) > 1 PATCH in 1 POUCH (0378-9119-16) > 72 h in 1 PATCH
FENTANYL-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 076258 ANDA Mylan Pharmaceuticals Inc. 0378-9121 0378-9121-98 5 POUCH in 1 CARTON (0378-9121-98) > 1 PATCH in 1 POUCH (0378-9121-16) > 72 h in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength25MCG/HR
Approval Date:Jan 28, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength50MCG/HR
Approval Date:Jan 28, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength75MCG/HR
Approval Date:Jan 28, 2005TE:ABRLD:No

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