Application 089804
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 1MG | No | No |
| 003 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 2.5MG | No | No |
| 004 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A089804-001 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1988-08-12 | ||
| A089804-002 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET / ORAL | 1988-08-12 | ||
| A089804-003 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | 1988-08-12 | ||
| A089804-004 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 1988-08-12 |
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 | A089804-001 | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1988-08-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A089804-002 | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET / ORAL | 1988-08-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A089804-003 | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | 1988-08-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A089804-004 | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 1988-08-12 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089804-001 | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1988-08-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089804-002 | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET / ORAL | 1988-08-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089804-003 | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | 1988-08-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089804-004 | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 1988-08-12 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A089804-001 | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1988-08-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A089804-002 | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET / ORAL | 1988-08-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A089804-003 | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | 1988-08-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A089804-004 | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 1988-08-12 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089804-001 | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1988-08-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089804-002 | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET / ORAL | 1988-08-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089804-003 | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | 1988-08-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089804-004 | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 1988-08-12 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089804-001 | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1988-08-12 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089804-002 | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET / ORAL | 1988-08-12 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089804-003 | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | 1988-08-12 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089804-004 | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 1988-08-12 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089804-001 | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1988-08-12 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089804-002 | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET / ORAL | 1988-08-12 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089804-003 | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | 1988-08-12 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089804-004 | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 1988-08-12 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089804-001 | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1988-08-12 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089804-002 | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET / ORAL | 1988-08-12 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089804-003 | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | 1988-08-12 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089804-004 | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 1988-08-12 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089804-001 | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1988-08-12 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089804-002 | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET / ORAL | 1988-08-12 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089804-003 | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | 1988-08-12 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089804-004 | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 1988-08-12 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089804-001 | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1988-08-12 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089804-002 | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET / ORAL | 1988-08-12 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089804-003 | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | 1988-08-12 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089804-004 | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 1988-08-12 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A089804-001 | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1988-08-12 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A089804-002 | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET / ORAL | 1988-08-12 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A089804-003 | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | 1988-08-12 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A089804-004 | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 1988-08-12 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A089804-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A089804-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A089804-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A089804-004 | AB | 1 | 74a2ff9319b5… |
| 2020-11-12 02:37 UTC | 2020-11 | A089804-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A089804-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A089804-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A089804-004 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A089804-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A089804-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A089804-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A089804-004 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A089804-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A089804-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A089804-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A089804-004 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A089804-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A089804-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A089804-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A089804-004 | AB | 1 | ea99ee380514… |
| 2023-05-13 08:27 UTC | 2023-05 | A089804-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A089804-002 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A089804-003 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A089804-004 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A089804-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A089804-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A089804-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A089804-004 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A089804-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A089804-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A089804-003 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A089804-004 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A089804-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A089804-002 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A089804-003 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A089804-004 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A089804-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A089804-002 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A089804-003 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A089804-004 | 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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-6004 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6004 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6009 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6009 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6074 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6074 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6097 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6097 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0615-1501 | Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-3574 | Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 51079-485 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-485 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-485 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-486 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-486 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-486 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-487 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-487 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-487 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-488 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-488 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-488 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 53808-0247 | Fluphenazine Hydrochloride | FLUPHENAZINE HYDROCHLORIDE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0600 | Fluphenazine Hydrochloride | FLUPHENAZINE HYDROCHLORIDE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 70518-0457 | Fluphenazine hydrochloride | Fluphenazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |