Application 077312
- Type
- ANDA
- Sponsor
- PAR PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FENTANYL CITRATE | FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.2MG BASE | No | No |
| 002 | FENTANYL CITRATE | FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.4MG BASE | No | No |
| 003 | FENTANYL CITRATE | FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.6MG BASE | No | No |
| 004 | FENTANYL CITRATE | FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 0.8MG BASE | No | No |
| 005 | FENTANYL CITRATE | FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 1.2MG BASE | No | No |
| 006 | FENTANYL CITRATE | FENTANYL CITRATE | TROCHE/LOZENGE;TRANSMUCOSAL | EQ 1.6MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077312-001 | FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.2MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | ||
| A077312-002 | FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.4MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | ||
| A077312-003 | FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.6MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | ||
| A077312-004 | FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.8MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | ||
| A077312-005 | FENTANYL CITRATE | FENTANYL CITRATE | EQ 1.2MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | ||
| A077312-006 | FENTANYL CITRATE | FENTANYL CITRATE | EQ 1.6MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077312-003 | FENTANYL CITRATE | EQ 0.6MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077312-004 | FENTANYL CITRATE | EQ 0.8MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077312-005 | FENTANYL CITRATE | EQ 1.2MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077312-006 | FENTANYL CITRATE | EQ 1.6MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077312-001 | FENTANYL CITRATE | EQ 0.2MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077312-002 | FENTANYL CITRATE | EQ 0.4MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077312-003 | FENTANYL CITRATE | EQ 0.6MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077312-004 | FENTANYL CITRATE | EQ 0.8MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077312-005 | FENTANYL CITRATE | EQ 1.2MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077312-006 | FENTANYL CITRATE | EQ 1.6MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077312-001 | FENTANYL CITRATE | EQ 0.2MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077312-002 | FENTANYL CITRATE | EQ 0.4MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077312-003 | FENTANYL CITRATE | EQ 0.6MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077312-004 | FENTANYL CITRATE | EQ 0.8MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077312-005 | FENTANYL CITRATE | EQ 1.2MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077312-006 | FENTANYL CITRATE | EQ 1.6MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077312-001 | FENTANYL CITRATE | EQ 0.2MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077312-002 | FENTANYL CITRATE | EQ 0.4MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077312-003 | FENTANYL CITRATE | EQ 0.6MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077312-004 | FENTANYL CITRATE | EQ 0.8MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077312-005 | FENTANYL CITRATE | EQ 1.2MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077312-006 | FENTANYL CITRATE | EQ 1.6MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077312-001 | FENTANYL CITRATE | EQ 0.2MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077312-002 | FENTANYL CITRATE | EQ 0.4MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077312-003 | FENTANYL CITRATE | EQ 0.6MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077312-004 | FENTANYL CITRATE | EQ 0.8MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077312-005 | FENTANYL CITRATE | EQ 1.2MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077312-006 | FENTANYL CITRATE | EQ 1.6MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077312-001 | FENTANYL CITRATE | EQ 0.2MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077312-002 | FENTANYL CITRATE | EQ 0.4MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077312-003 | FENTANYL CITRATE | EQ 0.6MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077312-004 | FENTANYL CITRATE | EQ 0.8MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077312-005 | FENTANYL CITRATE | EQ 1.2MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077312-006 | FENTANYL CITRATE | EQ 1.6MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077312-001 | FENTANYL CITRATE | EQ 0.2MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077312-002 | FENTANYL CITRATE | EQ 0.4MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077312-003 | FENTANYL CITRATE | EQ 0.6MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077312-004 | FENTANYL CITRATE | EQ 0.8MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077312-005 | FENTANYL CITRATE | EQ 1.2MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077312-006 | FENTANYL CITRATE | EQ 1.6MG BASE | TROCHE/LOZENGE / TRANSMUCOSAL | 2009-10-30 | 4b0b4de00fa7… |
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 Citrate | FENTANYL CITRATE | Hospira, Inc. | bfa8018a-4cbc-434b-e09e-782872b0340a | 2026-08-24 | Boxed warning, Warnings, Adverse reactions | Fentanyl Citrate FENTANYL CITRATE |
| 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 | 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 | FENTANYL CITRATE | Civica, Inc. | aacf276b-e133-4199-ad3f-67b894744c04 | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | Fentanyl Citrate 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 | FENTANYL CITRATE | Hikma Pharmaceuticals USA Inc. | c5fcdcbd-1dd1-4ebf-aa0d-edfe845414b7 | 2025-12-19 | Boxed warning, Warnings, Adverse reactions | Fentanyl Citrate FENTANYL CITRATE |
| 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 | FENTANYL CITRATE | Fresenius Kabi USA, LLC | 38d0c14a-a0c1-44cc-a939-0304eb8037d6 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Fentanyl Citrate FENTANYL CITRATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.