Application 020195
- Type
- NDA
- Sponsor
- CEPHALON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FENTANYL | FENTANYL CITRATE | TROCHE/LOZENGE;ORAL | EQ 0.2MG BASE | No | No |
| 002 | FENTANYL | FENTANYL CITRATE | TROCHE/LOZENGE;ORAL | EQ 0.3MG BASE | No | No |
| 003 | FENTANYL | FENTANYL CITRATE | TROCHE/LOZENGE;ORAL | EQ 0.4MG BASE | No | No |
| 007 | FENTANYL | FENTANYL CITRATE | TROCHE/LOZENGE;ORAL | EQ 0.1MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020195-001 | FENTANYL | FENTANYL CITRATE | EQ 0.2MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | ||
| N020195-002 | FENTANYL | FENTANYL CITRATE | EQ 0.3MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | ||
| N020195-003 | FENTANYL | FENTANYL CITRATE | EQ 0.4MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | ||
| N020195-007 | FENTANYL | FENTANYL CITRATE | EQ 0.1MG BASE | TROCHE/LOZENGE / ORAL | 1995-10-30 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020195-001 | FENTANYL | EQ 0.2MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020195-002 | FENTANYL | EQ 0.3MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020195-003 | FENTANYL | EQ 0.4MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020195-007 | FENTANYL | EQ 0.1MG BASE | TROCHE/LOZENGE / ORAL | 1995-10-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020195-001 | FENTANYL | EQ 0.2MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020195-002 | FENTANYL | EQ 0.3MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020195-003 | FENTANYL | EQ 0.4MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020195-007 | FENTANYL | EQ 0.1MG BASE | TROCHE/LOZENGE / ORAL | 1995-10-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020195-001 | FENTANYL | EQ 0.2MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020195-002 | FENTANYL | EQ 0.3MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020195-003 | FENTANYL | EQ 0.4MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020195-007 | FENTANYL | EQ 0.1MG BASE | TROCHE/LOZENGE / ORAL | 1995-10-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020195-001 | FENTANYL | EQ 0.2MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020195-002 | FENTANYL | EQ 0.3MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020195-003 | FENTANYL | EQ 0.4MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020195-007 | FENTANYL | EQ 0.1MG BASE | TROCHE/LOZENGE / ORAL | 1995-10-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020195-001 | FENTANYL | EQ 0.2MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020195-002 | FENTANYL | EQ 0.3MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020195-003 | FENTANYL | EQ 0.4MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020195-007 | FENTANYL | EQ 0.1MG BASE | TROCHE/LOZENGE / ORAL | 1995-10-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020195-001 | FENTANYL | EQ 0.2MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020195-002 | FENTANYL | EQ 0.3MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020195-003 | FENTANYL | EQ 0.4MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020195-007 | FENTANYL | EQ 0.1MG BASE | TROCHE/LOZENGE / ORAL | 1995-10-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020195-001 | FENTANYL | EQ 0.2MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020195-002 | FENTANYL | EQ 0.3MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020195-003 | FENTANYL | EQ 0.4MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020195-007 | FENTANYL | EQ 0.1MG BASE | TROCHE/LOZENGE / ORAL | 1995-10-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020195-001 | FENTANYL | EQ 0.2MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020195-002 | FENTANYL | EQ 0.3MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020195-003 | FENTANYL | EQ 0.4MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020195-007 | FENTANYL | EQ 0.1MG BASE | TROCHE/LOZENGE / ORAL | 1995-10-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020195-001 | FENTANYL | EQ 0.2MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020195-002 | FENTANYL | EQ 0.3MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020195-003 | FENTANYL | EQ 0.4MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020195-007 | FENTANYL | EQ 0.1MG BASE | TROCHE/LOZENGE / ORAL | 1995-10-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020195-001 | FENTANYL | EQ 0.2MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020195-002 | FENTANYL | EQ 0.3MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020195-003 | FENTANYL | EQ 0.4MG BASE | TROCHE/LOZENGE / ORAL | 1993-10-04 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020195-007 | FENTANYL | EQ 0.1MG BASE | TROCHE/LOZENGE / ORAL | 1995-10-30 | d06236e962d9… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| FENTANYL | FENTANYL | Aveva Drug Delivery Systems Inc. | 73897c38-e4ec-40bc-9f41-3359ee23a5a8 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | FENTANYL |
| FENTANYL | FENTANYL | INGENUS PHARMACEUTICALS, LLC | bf02ffd0-cc5d-446b-b648-378f6885052f | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | FENTANYL |
| FENTANYL CITRATE | FENTANYL CITRATE | Hospira, Inc. | 1ed25b2c-334e-4021-ada1-3396f07630dc | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | FENTANYL CITRATE |
| Fentanyl Citrate | FENTANYL CITRATE | Hikma Pharmaceuticals USA Inc. | ce5db1c2-feb1-4ad2-847a-d02e865bd47e | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | FENTANYL CITRATE |
| Fentanyl Citrate | FENTANYL CITRATE | Hospira, Inc. | bfa8018a-4cbc-434b-e09e-782872b0340a | 2026-02-25 | Boxed warning, Warnings, Adverse reactions | FENTANYL CITRATE |
| Fentanyl Citrate | FENTANYL CITRATE | Teva Pharmaceuticals USA, Inc. | 78221eab-66fd-4cd8-9c81-af52eb83671c | 2026-01-31 | Boxed warning, Warnings, Adverse reactions | FENTANYL CITRATE |
| Fentanyl Citrate | FENTANYL CITRATE | Civica, Inc. | aacf276b-e133-4199-ad3f-67b894744c04 | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | FENTANYL CITRATE |
| Fentanyl Citrate | FENTANYL CITRATE | Phlow Corp. | 58dcd3f7-e3d8-4929-a186-8f680a51ff11 | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | FENTANYL CITRATE |
| Fentanyl Citrate | FENTANYL CITRATE | Hikma Pharmaceuticals USA Inc. | c5fcdcbd-1dd1-4ebf-aa0d-edfe845414b7 | 2025-12-19 | Boxed warning, Warnings, Adverse reactions | FENTANYL CITRATE |
| FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | 2a2238e9-4b5d-c56d-8663-dd354ff9ae0c | 2025-12-15 | Boxed warning, Warnings, Adverse reactions | FENTANYL |
| Fentanyl Citrate | FENTANYL CITRATE | Fresenius Kabi USA, LLC | 0c10e465-4117-48ba-a454-23ccb7a3fcc7 | 2025-09-24 | Boxed warning, Warnings, Adverse reactions | FENTANYL CITRATE |
| Fentanyl Citrate | FENTANYL CITRATE | Fresenius Kabi USA, LLC | 38d0c14a-a0c1-44cc-a939-0304eb8037d6 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | FENTANYL CITRATE |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 41213 | SUPPL | 1999-08-02 |