Application 071132
- Type
- ANDA
- Sponsor
- CYCLE PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 10MG | No | No |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-05-31 18:47 UTC | 2024-05 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1987-05-12 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1987-05-12 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1987-05-12 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1987-05-12 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | 1987-05-12 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1987-05-12 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1987-05-12 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | 1987-05-12 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | 1987-05-12 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | 1987-05-12 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | 1987-05-12 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | 1987-05-12 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | 1987-05-12 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | 1987-05-12 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1987-05-12 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1987-05-12 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1987-05-12 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1987-05-12 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1987-05-12 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1987-05-12 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1987-05-12 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1987-05-12 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1987-05-12 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1987-05-12 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1987-05-12 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1987-05-12 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A071132-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1987-05-12 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-05-31 18:47 UTC | 2024-05 | A071132-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A071132-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A071132-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A071132-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A071132-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A071132-001 | AB | 1 | 782e0a99824c… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071132-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A071132-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A071132-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A071132-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A071132-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A071132-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A071132-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A071132-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A071132-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A071132-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A071132-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A071132-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A071132-001 | AB | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Haloperidol | HALOPERIDOL LACTATE | Fresenius Kabi USA, LLC | b1ad2abd-a9d6-44e3-957b-36a73260f4f5 | 2022-01-25 | Boxed warning, Warnings, Adverse reactions | Haloperidol |
| HALOPERIDOL | HALOPERIDOL LACTATE | HF Acquisition Co LLC, DBA HealthFirst | beb6d1cf-98db-d0a5-e053-2995a90ace90 | 2021-03-29 | Boxed warning, Warnings, Adverse reactions | HALOPERIDOL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.