Application Information

This drug has been submitted to the FDA under the reference 022510/001.

Names and composition

"ABSTRAL" is the commercial name of a drug composed of FENTANYL CITRATE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
022510/001 ABSTRAL FENTANYL CITRATE TABLET/SUBLINGUAL EQ 0.1MG BASE
022510/002 ABSTRAL FENTANYL CITRATE TABLET/SUBLINGUAL EQ 0.2MG BASE
022510/003 ABSTRAL FENTANYL CITRATE TABLET/SUBLINGUAL EQ 0.3MG BASE
022510/004 ABSTRAL FENTANYL CITRATE TABLET/SUBLINGUAL EQ 0.4MG BASE
022510/005 ABSTRAL FENTANYL CITRATE TABLET/SUBLINGUAL EQ 0.6MG BASE
022510/006 ABSTRAL FENTANYL CITRATE TABLET/SUBLINGUAL EQ 0.8MG BASE

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
016619/001 SUBLIMAZE PRESERVATIVE FREE FENTANYL CITRATE INJECTABLE/INJECTION EQ 0.05MG BASE per ML
019101/001 FENTANYL CITRATE PRESERVATIVE FREE FENTANYL CITRATE INJECTABLE/INJECTION EQ 0.05MG BASE per ML
019115/001 FENTANYL CITRATE FENTANYL CITRATE INJECTABLE/INJECTION EQ 0.05MG BASE per ML
020195/001 FENTANYL FENTANYL CITRATE TROCHE/LOZENGE/ORAL EQ 0.2MG BASE
020195/002 FENTANYL FENTANYL CITRATE TROCHE/LOZENGE/ORAL EQ 0.3MG BASE
020195/003 FENTANYL FENTANYL CITRATE TROCHE/LOZENGE/ORAL EQ 0.4MG BASE
020195/007 FENTANYL FENTANYL CITRATE TROCHE/LOZENGE/ORAL EQ 0.1MG BASE
020747/001 ACTIQ FENTANYL CITRATE TROCHE/LOZENGE/TRANSMUCOSAL EQ 0.2MG BASE
020747/002 ACTIQ FENTANYL CITRATE TROCHE/LOZENGE/TRANSMUCOSAL EQ 0.4MG BASE
020747/003 ACTIQ FENTANYL CITRATE TROCHE/LOZENGE/TRANSMUCOSAL EQ 0.6MG BASE
020747/004 ACTIQ FENTANYL CITRATE TROCHE/LOZENGE/TRANSMUCOSAL EQ 0.8MG BASE
020747/005 ACTIQ FENTANYL CITRATE TROCHE/LOZENGE/TRANSMUCOSAL EQ 1.2MG BASE
020747/006 ACTIQ FENTANYL CITRATE TROCHE/LOZENGE/TRANSMUCOSAL EQ 1.6MG BASE
021947/001 FENTORA FENTANYL CITRATE TABLET/BUCCAL, SUBLINGUAL EQ 0.1MG BASE
021947/002 FENTORA FENTANYL CITRATE TABLET/BUCCAL, SUBLINGUAL EQ 0.2MG BASE
021947/003 FENTORA FENTANYL CITRATE TABLET/BUCCAL, SUBLINGUAL EQ 0.4MG BASE
021947/004 FENTORA FENTANYL CITRATE TABLET/BUCCAL, SUBLINGUAL EQ 0.6MG BASE
021947/005 FENTORA FENTANYL CITRATE TABLET/BUCCAL, SUBLINGUAL EQ 0.8MG BASE
021947/006 FENTORA FENTANYL CITRATE TABLET/BUCCAL, SUBLINGUAL EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
022266/001 ONSOLIS FENTANYL CITRATE FILM/BUCCAL EQ 0.2MG BASE
022266/002 ONSOLIS FENTANYL CITRATE FILM/BUCCAL EQ 0.4MG BASE
022266/003 ONSOLIS FENTANYL CITRATE FILM/BUCCAL EQ 0.6MG BASE
022266/004 ONSOLIS FENTANYL CITRATE FILM/BUCCAL EQ 0.8MG BASE
022266/005 ONSOLIS FENTANYL CITRATE FILM/BUCCAL EQ 1.2MG BASE
022510/001 ABSTRAL FENTANYL CITRATE TABLET/SUBLINGUAL EQ 0.1MG BASE
022510/002 ABSTRAL FENTANYL CITRATE TABLET/SUBLINGUAL EQ 0.2MG BASE
022510/003 ABSTRAL FENTANYL CITRATE TABLET/SUBLINGUAL EQ 0.3MG BASE
022510/004 ABSTRAL FENTANYL CITRATE TABLET/SUBLINGUAL EQ 0.4MG BASE
022510/005 ABSTRAL FENTANYL CITRATE TABLET/SUBLINGUAL EQ 0.6MG BASE
022510/006 ABSTRAL FENTANYL CITRATE TABLET/SUBLINGUAL EQ 0.8MG BASE
022569/001 LAZANDA FENTANYL CITRATE SPRAY, METERED/NASAL EQ 0.1MG BASE
022569/002 LAZANDA FENTANYL CITRATE SPRAY, METERED/NASAL EQ 0.4MG BASE
022569/003 LAZANDA FENTANYL CITRATE SPRAY, METERED/NASAL EQ 0.3MG BASE
070636/001 FENTANYL CITRATE FENTANYL CITRATE INJECTABLE/INJECTION EQ 0.05MG BASE per ML
070637/001 FENTANYL CITRATE FENTANYL CITRATE INJECTABLE/INJECTION EQ 0.05MG BASE per ML
072786/001 FENTANYL CITRATE PRESERVATIVE FREE FENTANYL CITRATE INJECTABLE/INJECTION EQ 0.05MG BASE per ML
073488/001 FENTANYL CITRATE FENTANYL CITRATE INJECTABLE/INJECTION EQ 0.05MG BASE per ML
074917/001 FENTANYL CITRATE PRESERVATIVE FREE FENTANYL CITRATE INJECTABLE/INJECTION EQ 0.05MG BASE per ML
077312/001 FENTANYL CITRATE FENTANYL CITRATE TROCHE/LOZENGE/TRANSMUCOSAL EQ 0.2MG BASE
077312/002 FENTANYL CITRATE FENTANYL CITRATE TROCHE/LOZENGE/TRANSMUCOSAL EQ 0.4MG BASE
077312/003 FENTANYL CITRATE FENTANYL CITRATE TROCHE/LOZENGE/TRANSMUCOSAL EQ 0.6MG BASE
077312/004 FENTANYL CITRATE FENTANYL CITRATE TROCHE/LOZENGE/TRANSMUCOSAL EQ 0.8MG BASE
077312/005 FENTANYL CITRATE FENTANYL CITRATE TROCHE/LOZENGE/TRANSMUCOSAL EQ 1.2MG BASE
077312/006 FENTANYL CITRATE FENTANYL CITRATE TROCHE/LOZENGE/TRANSMUCOSAL EQ 1.6MG BASE
078907/001 FENTANYL CITRATE FENTANYL CITRATE TROCHE/LOZENGE/TRANSMUCOSAL EQ 0.2MG BASE
078907/002 FENTANYL CITRATE FENTANYL CITRATE TROCHE/LOZENGE/TRANSMUCOSAL EQ 0.4MG BASE
078907/003 FENTANYL CITRATE FENTANYL CITRATE TROCHE/LOZENGE/TRANSMUCOSAL EQ 0.6MG BASE
078907/004 FENTANYL CITRATE FENTANYL CITRATE TROCHE/LOZENGE/TRANSMUCOSAL EQ 0.8MG BASE
078907/005 FENTANYL CITRATE FENTANYL CITRATE TROCHE/LOZENGE/TRANSMUCOSAL EQ 1.2MG BASE
078907/006 FENTANYL CITRATE FENTANYL CITRATE TROCHE/LOZENGE/TRANSMUCOSAL EQ 1.6MG BASE
079075/001 FENTANYL CITRATE FENTANYL CITRATE TABLET/BUCCAL, SUBLINGUAL EQ 0.1MG BASE
079075/002 FENTANYL CITRATE FENTANYL CITRATE TABLET/BUCCAL, SUBLINGUAL EQ 0.2MG BASE
079075/003 FENTANYL CITRATE FENTANYL CITRATE TABLET/BUCCAL, SUBLINGUAL EQ 0.4MG BASE
079075/004 FENTANYL CITRATE FENTANYL CITRATE TABLET/BUCCAL, SUBLINGUAL EQ 0.6MG BASE
079075/005 FENTANYL CITRATE FENTANYL CITRATE TABLET/BUCCAL, SUBLINGUAL EQ 0.8MG BASE

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