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Details for New Drug Application (NDA): 079075

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NDA 079075 describes FENTANYL CITRATE, which is a drug marketed by Mallinckrodt, Par Pharm, Hospira, Abbott, Watson Labs, Astrazeneca, West-ward Pharms Int, and Watson Labs Inc, and is included in fourteen NDAs. It is available from five suppliers. Additional details are available on the FENTANYL CITRATE profile page.

The generic ingredient in FENTANYL CITRATE is droperidol; fentanyl citrate. There are five drug master file entries for this compound. Additional details are available on the droperidol; fentanyl citrate profile page.

Summary for NDA: 079075

Tradename:
FENTANYL CITRATE
Applicant:
Watson Labs
Ingredient:
fentanyl citrate
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 079075

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 079075

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENTANYL CITRATE
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL 079075 ANDA Watson Laboratories, Inc. 0591-3571 0591-3571-96 7 BLISTER PACK in 1 CARTON (0591-3571-96) > 4 TABLET in 1 BLISTER PACK (0591-3571-04)
FENTANYL CITRATE
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL 079075 ANDA Watson Laboratories, Inc. 0591-3572 0591-3572-96 7 BLISTER PACK in 1 CARTON (0591-3572-96) > 4 TABLET in 1 BLISTER PACK (0591-3572-04)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;BUCCAL, SUBLINGUALStrengthEQ 0.1MG BASE
Approval Date:Jan 7, 2011TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;BUCCAL, SUBLINGUALStrengthEQ 0.2MG BASE
Approval Date:Jan 7, 2011TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;BUCCAL, SUBLINGUALStrengthEQ 0.4MG BASE
Approval Date:Jan 7, 2011TE:RLD:No


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