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Details for New Drug Application (NDA): 077449

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NDA 077449 describes FENTANYL-75, which is a drug marketed by Actavis Labs Ut Inc, Aveva, Lavipharm Labs, Mallinckrodt Inc, Mylan Technologies, Par Pharm Inc, Noven, and 3m Drug Delivery, and is included in eight NDAs. It is available from nineteen 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-three suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the fentanyl profile page.

Summary for NDA: 077449

Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 077449

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 077449

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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

Summary for product number 001

Approval Date:Oct 20, 2008TE:ABRLD:No

Summary for product number 002

Approval Date:Oct 20, 2008TE:ABRLD:No

Summary for product number 003

Approval Date:Oct 20, 2008TE:ABRLD:No

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