Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020195
Company: CEPHALON
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. |