Application 089707
- Type
- ANDA
- Sponsor
- ANI PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PERPHENAZINE | PERPHENAZINE | TABLET;ORAL | 2MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A089707-001 | PERPHENAZINE | PERPHENAZINE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1987-09-10 |
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| 2026-07 | A089707-001 | PERPHENAZINE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1987-09-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A089707-001 | PERPHENAZINE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1987-09-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089707-001 | PERPHENAZINE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1987-09-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A089707-001 | PERPHENAZINE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1987-09-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089707-001 | PERPHENAZINE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1987-09-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089707-001 | PERPHENAZINE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1987-09-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089707-001 | PERPHENAZINE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1987-09-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089707-001 | PERPHENAZINE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1987-09-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089707-001 | PERPHENAZINE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1987-09-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089707-001 | PERPHENAZINE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1987-09-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A089707-001 | PERPHENAZINE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1987-09-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089707-001 | PERPHENAZINE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1987-09-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A089707-001 | PERPHENAZINE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1987-09-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A089707-001 | PERPHENAZINE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1987-09-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A089707-001 | PERPHENAZINE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1987-09-10 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A089707-001 | PERPHENAZINE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1987-09-10 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A089707-001 | PERPHENAZINE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1987-09-10 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A089707-001 | PERPHENAZINE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1987-09-10 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A089707-001 | PERPHENAZINE | 2MG | TABLET / ORAL | 1987-09-10 | 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 |
|---|---|---|---|---|---|---|
| Perphenazine | PERPHENAZINE | REMEDYREPACK INC. | 9588d223-41e4-4bb2-9306-f082498404c5 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | REMEDYREPACK INC. | cf41a02d-c881-4b40-b99c-d5b79dbd645b | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | REMEDYREPACK INC. | da5519cd-7b96-4468-910c-87dffdb1888e | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | REMEDYREPACK INC. | fc903628-248c-4d12-88b4-a551aeadb4d2 | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | REMEDYREPACK INC. | bb08cedf-18ab-4341-a84e-c092ff7a5c98 | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| perphenazine | PERPHENAZINE | REMEDYREPACK INC. | 1fc98e41-17d1-4491-87ed-ff7651422b5b | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | REMEDYREPACK INC. | 1a216d3f-12b0-44c2-b7d3-109fee45978d | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | REMEDYREPACK INC. | 8028ab47-a6de-4924-a4cd-9336fa90dd90 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | Chartwell RX, LLC | ba5f3963-3080-48bc-806a-0aed72e2c25b | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | American Health Packaging | a17c90f9-3d5d-4503-ba2c-754b45decbf8 | 2025-11-18 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | Bryant Ranch Prepack | aaa1127a-393d-454a-b68a-b1f206117f3b | 2025-10-28 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| PERPHENAZINE | PERPHENAZINE | REMEDYREPACK INC. | c4150683-0772-4344-bb1c-f050b84175d6 | 2025-09-26 | Boxed warning, Warnings, Adverse reactions | PERPHENAZINE PERPHENAZINE |
| Perphenazine | PERPHENAZINE | Bryant Ranch Prepack | f6af1fc3-868d-46f3-8bbe-828375fb0fae | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | Bryant Ranch Prepack | e2e52bd9-b9c2-4f04-af03-bdb54b48c16c | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | Bryant Ranch Prepack | afaea32d-0dc1-4dcb-9ee2-dd2937ec030e | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | Bryant Ranch Prepack | 41758282-6848-4a47-bbf3-89edc270f7b3 | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | Major Pharmaceuticals | 0dc77ea9-32ee-4b6d-b69d-8c712bcf5fe4 | 2025-04-15 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| Perphenazine | PERPHENAZINE | Actavis Pharma, Inc. | bb1a3d20-1f93-48a1-9e27-4712a8561757 | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | Perphenazine PERPHENAZINE |
| perphenazine | PERPHENAZINE | Golden State Medical Supply, Inc. | f0ea4d18-643d-7acb-e053-2a95a90a9ea7 | 2024-12-23 | Boxed warning, Warnings, Adverse reactions | perphenazine PERPHENAZINE |
| PERPHENAZINE | PERPHENAZINE | Rising Pharma Holdings, Inc. | 0ebf4c11-1810-42f6-a8e3-071616e33d5d | 2024-12-12 | Boxed warning, Warnings, Adverse reactions | PERPHENAZINE PERPHENAZINE |