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Generated: November 21, 2018

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Details for New Drug Application (NDA): 202097

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NDA 202097 describes FENTANYL-75, which is a drug marketed by 3m Drug Delivery, Actavis Labs Ut Inc, Aveva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, and Specgx Llc, and is included in eight NDAs. It is available from sixteen 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 suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
Summary for 202097
Tradename:FENTANYL-75
Applicant:3m Drug Delivery
Ingredient:fentanyl
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202097
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 202097
Suppliers and Packaging for NDA: 202097
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENTANYL-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 202097 ANDA Alvogen, Inc. 47781-423 47781-423-47 1 POUCH in 1 CARTON (47781-423-47) > 5 PATCH in 1 POUCH (47781-423-11)
FENTANYL-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 202097 ANDA Alvogen, Inc. 47781-424 47781-424-47 1 POUCH in 1 CARTON (47781-424-47) > 5 PATCH in 1 POUCH (47781-424-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength12.5MCG/HR
Approval Date:Nov 4, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength25MCG/HR
Approval Date:Nov 4, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength50MCG/HR
Approval Date:Nov 4, 2016TE:ABRLD:No

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