Application 218162
- Type
- ANDA
- Sponsor
- CREEKWOOD PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 0.5MG | No | No |
| 002 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 1MG | No | No |
| 003 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 2MG | No | No |
| 004 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 5MG | No | No |
| 005 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 10MG | No | No |
| 006 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 20MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218162-001 | HALOPERIDOL | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 2025-12-18 | |
| A218162-002 | HALOPERIDOL | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 2025-12-18 | |
| A218162-003 | HALOPERIDOL | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 2025-12-18 | |
| A218162-004 | HALOPERIDOL | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 2025-12-18 | |
| A218162-005 | HALOPERIDOL | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 2025-12-18 | |
| A218162-006 | HALOPERIDOL | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 2025-12-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218162-001 | AB |
| A218162-002 | AB |
| A218162-003 | AB |
| A218162-004 | AB |
| A218162-005 | AB |
| A218162-006 | AB |
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 | A218162-001 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 2025-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218162-002 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 2025-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218162-003 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 2025-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218162-004 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 2025-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218162-005 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 2025-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218162-006 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 2025-12-18 | 011fe1cb6892… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218162-001 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 2025-12-18 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218162-002 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 2025-12-18 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218162-003 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 2025-12-18 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218162-004 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 2025-12-18 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218162-005 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 2025-12-18 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218162-006 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 2025-12-18 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A218162-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218162-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218162-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218162-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218162-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218162-006 | AB | 1 | 011fe1cb6892… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218162-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218162-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218162-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218162-004 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218162-005 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218162-006 | AB | 1 | a50c72e98297… |
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 | Bryant Ranch Prepack | 57d77858-758c-41ce-a47c-ca42c4e88859 | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | 218162 ANDA218162 |
| HALOPERIDOL | HALOPERIDOL | Bryant Ranch Prepack | f6f6f2ed-33a5-4139-b2f1-ce446814e597 | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | 218162 ANDA218162 |
| HALOPERIDOL | HALOPERIDOL | Bryant Ranch Prepack | 7666e56f-9eef-4343-8a76-60613c4ca57f | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | 218162 ANDA218162 |
| HALOPERIDOL | HALOPERIDOL | Bryant Ranch Prepack | f6fb9e4c-630b-4f82-8223-f154dd6c17a2 | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | 218162 ANDA218162 |
| HALOPERIDOL | HALOPERIDOL | Bryant Ranch Prepack | 42549018-8f15-40b4-ac0a-8b06a2178e46 | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | 218162 ANDA218162 |
| HALOPERIDOL | HALOPERIDOL | Bryant Ranch Prepack | 7212f03f-caa0-43bc-aac5-9d8b3c304897 | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | 218162 ANDA218162 |
| HALOPERIDOL | HALOPERIDOL | Creekwood Pharmaceuticals LLC | 9763c044-7430-48f7-bf3e-da1c7c683955 | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | 218162 ANDA218162 |