Application 080381
- Type
- ANDA
- Sponsor
- SCHERING
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TREMIN | TRIHEXYPHENIDYL HYDROCHLORIDE | TABLET;ORAL | 2MG | No | No |
| 003 | TREMIN | TRIHEXYPHENIDYL HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A080381-001 | TREMIN | TRIHEXYPHENIDYL HYDROCHLORIDE | 2MG | TABLET / ORAL | Approved before 1982 | ||
| A080381-003 | TREMIN | TRIHEXYPHENIDYL HYDROCHLORIDE | 5MG | TABLET / ORAL | Approved before 1982 |
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 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A080381-001 | TREMIN | 2MG | TABLET / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A080381-003 | TREMIN | 5MG | TABLET / ORAL | Approved before 1982 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| TRIHEXYPHENIDYL HYDROCHLORIDE | TRIHEXYPHENIDYL HYDROCHLORIDE | REMEDYREPACK INC. | c25ea809-5bdf-4917-97f1-610059fbd0b7 | 2026-07-23 | Warnings, Adverse reactions | TRIHEXYPHENIDYL HYDROCHLORIDE |
| TRIHEXYPHENIDYL HYDROCHLORIDE | TRIHEXYPHENIDYL HYDROCHLORIDE | REMEDYREPACK INC. | b60ef86c-b8b6-4530-baaf-d4671ce961af | 2026-07-23 | Warnings, Adverse reactions | TRIHEXYPHENIDYL HYDROCHLORIDE |
| Trihexyphenidyl Hydrochloride | TRIHEXYPHENIDYL HYDROCHLORIDE | Chartwell RX, LLC | e8e2ac3b-80dc-4449-9365-2586d6d57e10 | 2026-07-17 | Warnings, Adverse reactions | TRIHEXYPHENIDYL HYDROCHLORIDE |
| Trihexyphenidyl Hydrochloride | TRIHEXYPHENIDYL HYDROCHLORIDE | REMEDYREPACK INC. | 86a65e8a-10f4-4f12-8e65-2edf398daeaa | 2026-07-09 | Warnings, Adverse reactions | TRIHEXYPHENIDYL HYDROCHLORIDE |
| Trihexyphenidyl Hydrochloride | TRIHEXYPHENIDYL HYDROCHLORIDE | REMEDYREPACK INC. | 3e71b957-9495-4583-8f00-99eac715ff85 | 2026-07-09 | Warnings, Adverse reactions | TRIHEXYPHENIDYL HYDROCHLORIDE |
| Trihexyphenidyl Hydrochloride | TRIHEXYPHENIDYL HYDROCHLORIDE | REMEDYREPACK INC. | 3ed3cdf1-1745-4c6f-bb90-fb7d9471270d | 2026-07-02 | Warnings, Adverse reactions | TRIHEXYPHENIDYL HYDROCHLORIDE |
| Trihexyphenidyl Hydrochloride | TRIHEXYPHENIDYL HYDROCHLORIDE | Bionpharma Inc. | 4d4d473e-4f84-43e7-bb17-49e8dc1e97fd | 2025-07-02 | Warnings, Adverse reactions | TRIHEXYPHENIDYL HYDROCHLORIDE |
| Trihexyphenidyl Hydrochloride | TRIHEXYPHENIDYL HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 9036c9f0-6d2d-4d0f-a20e-e36f9be228f7 | 2024-11-19 | Warnings, Adverse reactions | TRIHEXYPHENIDYL HYDROCHLORIDE |
| Trihexyphenidyl Hydrochloride | TRIHEXYPHENIDYL HYDROCHLORIDE | Actavis Pharma, Inc. | a44d7803-164d-4a67-9356-581c45de8596 | 2024-02-02 | Warnings, Adverse reactions | TRIHEXYPHENIDYL HYDROCHLORIDE |
| TRIHEXYPHENIDYL HYDROCHLORIDE | TRIHEXYPHENIDYL HYDROCHLORIDE | Golden State Medical Supply Inc. | 9040cb3b-13d2-e46d-e053-2a95a90ae9e6 | 2023-09-26 | Warnings, Adverse reactions | TRIHEXYPHENIDYL HYDROCHLORIDE |
| Trihexyphenidyl Hydrochloride | TRIHEXYPHENIDYL HYDROCHLORIDE | Akorn | 294cd88d-d9e8-4938-b4be-c3adc4a35de0 | 2022-06-21 | Warnings, Adverse reactions | TRIHEXYPHENIDYL HYDROCHLORIDE |
| Trihexyphenidyl Hydrochloride | TRIHEXYPHENIDYL HYDROCHLORIDE | Natco Pharma Limited | b7e4200c-feff-4537-aad1-cf9989fd8c14 | 2019-10-25 | Warnings, Adverse reactions | TRIHEXYPHENIDYL HYDROCHLORIDE |
| TRIHEXYPHENIDYL HYDROCHLORIDE | TRIHEXYPHENIDYL HYDROCHLORIDE | Novitium Pharma LLC | 83608c13-509d-448b-8559-5f5e8a9a0d75 | 2019-01-28 | Warnings, Adverse reactions | TRIHEXYPHENIDYL HYDROCHLORIDE |