Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020195
Company: CEPHALON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENTANYL FENTANYL CITRATE EQ 0.2MG BASE TROCHE/LOZENGE;ORAL Discontinued None No No
FENTANYL FENTANYL CITRATE EQ 0.3MG BASE TROCHE/LOZENGE;ORAL Discontinued None No No
FENTANYL FENTANYL CITRATE EQ 0.4MG BASE TROCHE/LOZENGE;ORAL Discontinued None No No
FENTANYL FENTANYL CITRATE EQ 0.1MG BASE TROCHE/LOZENGE;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/04/1993 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/01/2000 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/25/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1996 SUPPL-2 Efficacy-New Patient Population Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020195s002_fentanyl.pdf
10/30/1995 SUPPL-1 Efficacy-New Dosing Regimen

Label is not available on this site.

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