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Last Updated: January 15, 2021

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Details for New Drug Application (NDA): 077154

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NDA 077154 describes FENTANYL-75, which is a drug marketed by Actavis Labs Ut Inc, Aveva, Kindeva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, and Specgx Llc, and is included in eight NDAs. It is available from seven 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. Nine suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
Summary for 077154
Tradename:FENTANYL-75
Applicant:Specgx Llc
Ingredient:fentanyl
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077154
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 077154
Suppliers and Packaging for NDA: 077154
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENTANYL-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 077154 ANDA SpecGx LLC 0406-9000 0406-9000-76 5 POUCH in 1 CARTON (0406-9000-76) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH
FENTANYL-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 077154 ANDA SpecGx LLC 0406-9012 0406-9012-76 5 POUCH in 1 CARTON (0406-9012-76) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength25MCG/HR
Approval Date:Feb 9, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength50MCG/HR
Approval Date:Feb 9, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength75MCG/HR
Approval Date:Feb 9, 2011TE:ABRLD:No

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