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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 076258


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NDA 076258 describes FENTANYL-87, which is a drug marketed by Difgen Pharms, Mylan Technologies, and Zydus Pharms, and is included in three NDAs. It is available from six 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. Eight 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
Pharmacology for NDA: 076258
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 076258
Adjuvants, Anesthesia
Analgesics, Opioid
Anesthetics, Intravenous
Narcotics
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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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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