Application 206329
- Type
- ANDA
- Sponsor
- MAYNE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FENTANYL CITRATE | FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.1MG BASE | No | No |
| 002 | FENTANYL CITRATE | FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.2MG BASE | No | No |
| 003 | FENTANYL CITRATE | FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.3MG BASE | No | No |
| 004 | FENTANYL CITRATE | FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.4MG BASE | No | No |
| 005 | FENTANYL CITRATE | FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.6MG BASE | No | No |
| 006 | FENTANYL CITRATE | FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.8MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206329-001 | FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.1MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | ||
| A206329-002 | FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.2MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | ||
| A206329-003 | FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.3MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | ||
| A206329-004 | FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.4MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | ||
| A206329-005 | FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.6MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | ||
| A206329-006 | FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.8MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 |
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 | A206329-001 | FENTANYL CITRATE | EQ 0.1MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206329-002 | FENTANYL CITRATE | EQ 0.2MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206329-003 | FENTANYL CITRATE | EQ 0.3MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206329-004 | FENTANYL CITRATE | EQ 0.4MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206329-005 | FENTANYL CITRATE | EQ 0.6MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206329-006 | FENTANYL CITRATE | EQ 0.8MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206329-001 | FENTANYL CITRATE | EQ 0.1MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206329-002 | FENTANYL CITRATE | EQ 0.2MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206329-003 | FENTANYL CITRATE | EQ 0.3MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206329-004 | FENTANYL CITRATE | EQ 0.4MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206329-005 | FENTANYL CITRATE | EQ 0.6MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206329-006 | FENTANYL CITRATE | EQ 0.8MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206329-001 | FENTANYL CITRATE | EQ 0.1MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206329-002 | FENTANYL CITRATE | EQ 0.2MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206329-003 | FENTANYL CITRATE | EQ 0.3MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206329-004 | FENTANYL CITRATE | EQ 0.4MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206329-005 | FENTANYL CITRATE | EQ 0.6MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206329-006 | FENTANYL CITRATE | EQ 0.8MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206329-001 | FENTANYL CITRATE | EQ 0.1MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206329-002 | FENTANYL CITRATE | EQ 0.2MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206329-003 | FENTANYL CITRATE | EQ 0.3MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206329-004 | FENTANYL CITRATE | EQ 0.4MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206329-005 | FENTANYL CITRATE | EQ 0.6MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206329-006 | FENTANYL CITRATE | EQ 0.8MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206329-001 | FENTANYL CITRATE | EQ 0.1MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206329-002 | FENTANYL CITRATE | EQ 0.2MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206329-003 | FENTANYL CITRATE | EQ 0.3MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206329-004 | FENTANYL CITRATE | EQ 0.4MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206329-005 | FENTANYL CITRATE | EQ 0.6MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206329-006 | FENTANYL CITRATE | EQ 0.8MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206329-001 | FENTANYL CITRATE | EQ 0.1MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206329-002 | FENTANYL CITRATE | EQ 0.2MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206329-003 | FENTANYL CITRATE | EQ 0.3MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206329-004 | FENTANYL CITRATE | EQ 0.4MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206329-005 | FENTANYL CITRATE | EQ 0.6MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206329-006 | FENTANYL CITRATE | EQ 0.8MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206329-001 | FENTANYL CITRATE | EQ 0.1MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206329-002 | FENTANYL CITRATE | EQ 0.2MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206329-003 | FENTANYL CITRATE | EQ 0.3MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206329-004 | FENTANYL CITRATE | EQ 0.4MG BASE | TABLET / BUCCAL, SUBLINGUAL | 2022-08-22 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | A206329-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A206329-002 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A206329-004 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A206329-005 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A206329-006 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A206329-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A206329-002 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A206329-004 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A206329-005 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A206329-006 | AB | 1 | e64feba35796… |
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. | 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 | Hospira, Inc. | bfa8018a-4cbc-434b-e09e-782872b0340a | 2026-02-25 | Boxed warning, Warnings, Adverse reactions | Fentanyl Citrate 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 | 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 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76277 | ORIG | 2023-11-03 |