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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 077312


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NDA 077312 describes FENTANYL CITRATE, which is a drug marketed by Abbott, Fresenius Kabi Usa, Hikma, Hospira, Watson Labs, Exela Pharma, Dr Reddys Labs Sa, Actavis Labs Fl Inc, Par Pharm, Specgx Llc, Astrazeneca, and Dr Reddys, and is included in nineteen NDAs. It is available from seven 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 077312
Tradename:FENTANYL CITRATE
Applicant:Par Pharm
Ingredient:fentanyl citrate
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TROCHE/LOZENGE;TRANSMUCOSALStrengthEQ 0.2MG BASE
Approval Date:Oct 30, 2009TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TROCHE/LOZENGE;TRANSMUCOSALStrengthEQ 0.4MG BASE
Approval Date:Oct 30, 2009TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TROCHE/LOZENGE;TRANSMUCOSALStrengthEQ 0.6MG BASE
Approval Date:Oct 30, 2009TE:RLD:No

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