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Serving leading biopharmaceutical companies globally:

Merck
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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077449

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NDA 077449 describes FENTANYL-75, which is a drug marketed by 3m Drug Delivery, Actavis Labs Ut Inc, Aveva, Lavipharm Labs, Mallinckrodt Inc, Mayne Pharma, Mylan Technologies, and Noven, and is included in eight NDAs. It is available from eighteen 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-two suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
Summary for 077449
Tradename:FENTANYL-75
Applicant:Aveva
Ingredient:fentanyl
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 077449
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 077449
Suppliers and Packaging for NDA: 077449
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENTANYL-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 077449 ANDA Lake Erie Medical DBA Quality Care Products LLC 55700-402 55700-402-05 5 PATCH in 1 CARTON (55700-402-05) > 72 h in 1 PATCH
FENTANYL-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 077449 ANDA Apotex Corp. 60505-7006 60505-7006-2 5 POUCH in 1 CARTON (60505-7006-2) > 1 PATCH in 1 POUCH (60505-7006-0) > 72 h in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength25MCG/HR
Approval Date:Oct 20, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength50MCG/HR
Approval Date:Oct 20, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength75MCG/HR
Approval Date:Oct 20, 2008TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Cantor Fitzgerald
Queensland Health
Boehringer Ingelheim
Dow
Federal Trade Commission
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