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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 020195


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NDA 020195 describes FENTANYL, which is a drug marketed by Cephalon, Abbott, Fresenius Kabi Usa, Hikma, Hospira, Watson Labs, Exela Pharma, Dr Reddys Labs Sa, Actavis Labs Fl Inc, Par Pharm, Specgx Llc, Astrazeneca, Dr Reddys, Actavis Labs Ut Inc, Aveva, Kindeva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, and Zydus Pharms, and is included in twenty-nine NDAs. Additional details are available on the FENTANYL profile page.

The generic ingredient in FENTANYL is fentanyl. There are thirty-one drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
Summary for 020195
Tradename:FENTANYL
Applicant:Cephalon
Ingredient:fentanyl citrate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TROCHE/LOZENGE;ORALStrengthEQ 0.2MG BASE
Approval Date:Oct 4, 1993TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TROCHE/LOZENGE;ORALStrengthEQ 0.3MG BASE
Approval Date:Oct 4, 1993TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TROCHE/LOZENGE;ORALStrengthEQ 0.4MG BASE
Approval Date:Oct 4, 1993TE:RLD:No

Expired US Patents for NDA 020195

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon FENTANYL fentanyl citrate TROCHE/LOZENGE;ORAL 020195-007 Oct 30, 1995 ⤷  Try a Trial ⤷  Try a Trial
Cephalon FENTANYL fentanyl citrate TROCHE/LOZENGE;ORAL 020195-001 Oct 4, 1993 ⤷  Try a Trial ⤷  Try a Trial
Cephalon FENTANYL fentanyl citrate TROCHE/LOZENGE;ORAL 020195-003 Oct 4, 1993 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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