You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 25, 2024

Details for New Drug Application (NDA): 076258


✉ Email this page to a colleague

« Back to Dashboard


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 five 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
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.