Application 070533
- Type
- ANDA
- Sponsor
- APOTHECON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROLIXIN | FLUPHENAZINE HYDROCHLORIDE | CONCENTRATE;ORAL | 5MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A070533-001 | PROLIXIN | FLUPHENAZINE HYDROCHLORIDE | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A070533-001 | PROLIXIN | 5MG/ML | CONCENTRATE / ORAL | 1985-11-07 | 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 |
|---|---|---|---|---|---|---|
| Fluphenazine Hydrochoride | FLUPHENAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 91b85b8d-4c10-4395-915e-272b81ef3b12 | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |
| fluphenazine hydrochloride | FLUPHENAZINE HYDROCHLORIDE | Coupler LLC | 53864ae1-046e-f6de-e063-6294a90a13af | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |
| Fluphenazine Hydrochloride | FLUPHENAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 34395a69-d3d1-4295-8d57-ae92e2cdd992 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |
| Fluphenazine hydrochloride | FLUPHENAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 85720b55-3419-4e2c-95dd-22eec035d6f1 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |
| fluphenazine hydrochloride | FLUPHENAZINE HYDROCHLORIDE | Amneal Pharmaceuticals NY LLC | 5b443b30-5682-4cf3-9ed0-716efddbc865 | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |
| Fluphenazine Hydrochloride | FLUPHENAZINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 7036f7c6-0792-400d-a1c7-54f21b2bd481 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |
| Fluphenazine Hydrochloride | FLUPHENAZINE HYDROCHLORIDE | Glenmark Pharmaceuticals Inc., USA | 4c3eea71-a7a1-4eda-9871-034ddeb83ed6 | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |
| fluphenazine hydrochloride | FLUPHENAZINE HYDROCHLORIDE | Chartwell RX, LLC | 325af2a4-2280-4236-8cf8-44f5700ba73f | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |
| Fluphenazine Hydrochloride | FLUPHENAZINE HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 4dd61338-8e4b-41c6-99d8-811a8e990c4e | 2025-11-25 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | Marlex Pharmaceuticals, Inc. | c69f07b1-660c-db03-e053-2995a90a5464 | 2025-11-13 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |
| Fluphenazine hydrochloride | FLUPHENAZINE HYDROCHLORIDE | Ajanta Pharma USA Inc. | 47695e20-9c0b-4a6b-ab1a-1dfaa75e96d8 | 2025-11-04 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |
| Fluphenazine Hydrochoride | FLUPHENAZINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 9fd44ab9-79bb-472e-8434-c3d786b42de5 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |
| Fluphenazine Hydrochloride | FLUPHENAZINE HYDROCHLORIDE | Major Pharmaceuticals | e8d4065a-45fc-4adf-9406-2122ca131d99 | 2025-09-11 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |
| Fluphenazine Hydrochloride | FLUPHENAZINE HYDROCHLORIDE | Upsher-Smith Laboratories,LLC | f07bb3f1-c68c-441b-9de4-99a219f2500a | 2025-08-06 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |
| Fluphenazine Hydrochloride | FLUPHENAZINE HYDROCHLORIDE | Coupler LLC | 37c9712b-95a1-fcc4-e063-6394a90aca50 | 2025-06-17 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |
| Fluphenazine Hydrochloride | FLUPHENAZINE HYDROCHLORIDE | American Health Packaging | b6eadd59-a7d0-400e-ba1d-795b9243f77d | 2025-05-30 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |
| Fluphenazine Hydrochloride | FLUPHENAZINE HYDROCHLORIDE | Coupler LLC | 325c8c34-2858-af36-e063-6394a90a7814 | 2025-04-09 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |
| Fluphenazine Hydrochloride | FLUPHENAZINE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | f0a89d5d-01db-47f3-a873-33ab49c6e4f8 | 2025-02-07 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |
| Fluphenazine Hydrochloride | FLUPHENAZINE HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | 6218cbd2-1f7f-40fa-92d2-5d5b0d7fa60b | 2025-01-24 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |
| Fluphenazine Hydrochloride | FLUPHENAZINE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 0860b3f3-3116-40f8-bcb0-e5c47731bdc8 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | FLUPHENAZINE HYDROCHLORIDE |