Application 071173
- Type
- ANDA
- Sponsor
- INNOGENIX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 10MG | No | No |
| 002 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 0.5MG | No | No |
| 003 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 1MG | No | No |
| 004 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 2MG | No | No |
| 005 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 5MG | 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 |
|---|---|---|---|---|---|---|---|
| A071173-001 | HALOPERIDOL | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1988-01-07 | |
| A071173-002 | HALOPERIDOL | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 1987-01-02 | |
| A071173-003 | HALOPERIDOL | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 1987-01-02 | |
| A071173-004 | HALOPERIDOL | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 1987-01-02 | |
| A071173-005 | HALOPERIDOL | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 1988-01-07 | |
| A071173-006 | HALOPERIDOL | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 1988-01-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A071173-001 | AB |
| A071173-002 | AB |
| A071173-003 | AB |
| A071173-004 | AB |
| A071173-005 | AB |
| A071173-006 | 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 | A071173-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1988-01-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-002 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 1987-01-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-003 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 1987-01-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-004 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 1987-01-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-005 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 1988-01-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-006 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 1988-01-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1988-01-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-002 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 1987-01-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-003 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 1987-01-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-004 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 1987-01-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-005 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 1988-01-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-006 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 1988-01-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1988-01-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-002 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 1987-01-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-003 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 1987-01-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-004 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 1987-01-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-005 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 1988-01-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-006 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 1988-01-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1988-01-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-002 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 1987-01-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-003 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 1987-01-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-004 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 1987-01-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-005 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 1988-01-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-006 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 1988-01-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1988-01-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-002 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 1987-01-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-003 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 1987-01-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-004 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 1987-01-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-005 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 1988-01-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-006 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 1988-01-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1988-01-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-002 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 1987-01-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-003 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 1987-01-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-004 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 1987-01-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-005 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 1988-01-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-006 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 1988-01-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071173-001 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 1988-01-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071173-002 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 1987-01-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071173-003 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 1987-01-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071173-004 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 1987-01-02 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A071173-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A071173-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071173-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A071173-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071173-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071173-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071173-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071173-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071173-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071173-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071173-004 | AB | 1 | 2680178bc6a6… |
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 | REMEDYREPACK INC. | 861c7b75-572c-48c2-adf9-1ca3fc3db19b | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 70518-2682 |
| Haloperidol | HALOPERIDOL | REMEDYREPACK INC. | a3afd19a-c340-4fad-8ddd-d71242515345 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 70518-3587 |
| Haloperidol | HALOPERIDOL | REMEDYREPACK INC. | 22598f07-501b-471a-b512-449d95e2301c | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 70518-3608 |
| Haloperidol | HALOPERIDOL | REMEDYREPACK INC. | 051f3c99-7d16-4185-a857-c90440e1b1c5 | 2026-02-16 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 70518-3021 |
| Haloperidol | HALOPERIDOL | REMEDYREPACK INC. | eb69959d-5967-41ac-a222-ff4416869dfc | 2026-02-10 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 70518-2680 |
| Haloperidol | HALOPERIDOL | REMEDYREPACK INC. | b5a6c54c-fb70-4132-90ae-7d75b5e9c9de | 2026-02-10 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 70518-2687 |
| Haloperidol | HALOPERIDOL | Innogenix, Inc. | 2c26af24-5ed3-4eb7-8d29-d6a019320a70 | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 71247-153 71247-152 71247-154 71247-155 71247-151 71247-150 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | 966db55f-3f12-4653-9668-1beff85df0ab | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | 5f4d945e-97f0-4afc-88d6-9b55ec238686 | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | 9353117e-bd01-441a-b35f-fd1352c5df8c | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | 457b8b71-8acf-47f1-93e5-1d353e53af10 | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | 2cffe2ad-3dad-479e-a91a-b41c3dd05ce1 | 2025-10-28 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Coupler LLC | 38f59751-4741-f588-e063-6294a90a6528 | 2025-07-02 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Method Pharmaceuticals, LLC | 87f8773b-bf89-4f7e-bff4-8cad117d5776 | 2025-06-29 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 58657-702 58657-704 58657-700 58657-701 58657-705 58657-703 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | 490efba9-70f1-46b8-9d62-2f96163e25df | 2025-06-26 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | e8977803-08a2-4ad0-87d5-63d81c98a536 | 2024-12-27 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Marlex Pharmaceuticals, Inc. | e7a61604-741f-2d3b-e053-2995a90a62fc | 2024-10-07 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 10135-757 10135-753 10135-754 10135-752 10135-755 10135-756 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | d9d0e530-02cd-4631-b3c8-cf6de521fd5b | 2024-10-04 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | df340d75-7387-4084-9d76-167283ee7462 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 63629-2326 |
| Haloperidol | HALOPERIDOL | Bryant Ranch Prepack | d896823a-fb08-4777-a1f1-cef85fc8d96c | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | 071173 ANDA071173 63629-9275 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-7240 | Haloperidol | Haloperidol | Major Pharmaceuticals | ANDA | Current |
| 0904-7241 | Haloperidol | Haloperidol | Major Pharmaceuticals | ANDA | Current |
| 0904-7242 | Haloperidol | Haloperidol | Major Pharmaceuticals | ANDA | Current |
| 10135-752 | Haloperidol | Haloperidol | Marlex Pharmaceuticals, Inc. | ANDA | Current |
| 10135-753 | Haloperidol | Haloperidol | Marlex Pharmaceuticals, Inc. | ANDA | Current |
| 10135-754 | Haloperidol | Haloperidol | Marlex Pharmaceuticals, Inc. | ANDA | Current |
| 10135-755 | Haloperidol | Haloperidol | Marlex Pharmaceuticals, Inc. | ANDA | Current |
| 10135-756 | Haloperidol | Haloperidol | Marlex Pharmaceuticals, Inc. | ANDA | Current |
| 10135-757 | Haloperidol | Haloperidol | Marlex Pharmaceuticals, Inc. | ANDA | Current |
| 17856-0730 | Haloperidol | Haloperidol | ATLANTIC BIOLOGICALS CORP. | ANDA | Current |
| 50090-5989 | Haloperidol | Haloperidol | A-S Medication Solutions | ANDA | Current |
| 58657-700 | Haloperidol | Haloperidol | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-700 | Haloperidol | Haloperidol | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-701 | Haloperidol | Haloperidol | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-701 | Haloperidol | Haloperidol | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-702 | Haloperidol | Haloperidol | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-702 | Haloperidol | Haloperidol | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-703 | Haloperidol | Haloperidol | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-703 | Haloperidol | Haloperidol | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-704 | Haloperidol | Haloperidol | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-704 | Haloperidol | Haloperidol | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-705 | Haloperidol | Haloperidol | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-705 | Haloperidol | Haloperidol | Method Pharmaceuticals, LLC | ANDA | Current |
| 63629-2326 | Haloperidol | Haloperidol | Bryant Ranch Prepack | ANDA | Current |
| 63629-2326 | Haloperidol | Haloperidol | Bryant Ranch Prepack | ANDA | Current |
| 63629-9270 | Haloperidol | Haloperidol | Bryant Ranch Prepack | ANDA | Current |
| 63629-9271 | Haloperidol | Haloperidol | Bryant Ranch Prepack | ANDA | Current |
| 63629-9272 | Haloperidol | Haloperidol | Bryant Ranch Prepack | ANDA | Current |
| 63629-9273 | Haloperidol | Haloperidol | Bryant Ranch Prepack | ANDA | Current |
| 63629-9274 | Haloperidol | Haloperidol | Bryant Ranch Prepack | ANDA | Current |
| 63629-9275 | Haloperidol | Haloperidol | Bryant Ranch Prepack | ANDA | Current |
| 69292-580 | Haloperidol | Haloperidol | Amici Pharmaceuticals, LLC | ANDA | Current |
| 69292-582 | Haloperidol | Haloperidol | Amici Pharmaceuticals, LLC | ANDA | Current |
| 69292-584 | Haloperidol | Haloperidol | Amici Pharmaceuticals, LLC | ANDA | Current |
| 69292-586 | Haloperidol | Haloperidol | Amici Pharmaceuticals, LLC | ANDA | Current |
| 69292-588 | Haloperidol | Haloperidol | Amici Pharmaceuticals, LLC | ANDA | Current |
| 69292-590 | Haloperidol | Haloperidol | Amici Pharmaceuticals, LLC | ANDA | Current |
| 70518-2680 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 70518-2680 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 70518-2680 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 70518-2680 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 70518-2682 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 70518-2682 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 70518-2682 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 70518-2682 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 70518-2687 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 70518-2687 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 70518-2687 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 70518-2687 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 70518-3021 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 70518-3437 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 70518-3437 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 70518-3440 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 70518-3500 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 70518-3587 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 70518-3608 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 71247-150 | Haloperidol | Haloperidol | Innogenix, Inc. | ANDA | Current |
| 71247-150 | Haloperidol | Haloperidol | Innogenix, Inc. | ANDA | Current |
| 71247-151 | Haloperidol | Haloperidol | Innogenix, Inc. | ANDA | Current |
| 71247-151 | Haloperidol | Haloperidol | Innogenix, Inc. | ANDA | Current |
| 71247-152 | Haloperidol | Haloperidol | Innogenix, Inc. | ANDA | Current |
| 71247-152 | Haloperidol | Haloperidol | Innogenix, Inc. | ANDA | Current |
| 71247-153 | Haloperidol | Haloperidol | Innogenix, Inc. | ANDA | Current |
| 71247-153 | Haloperidol | Haloperidol | Innogenix, Inc. | ANDA | Current |
| 71247-154 | Haloperidol | Haloperidol | Innogenix, Inc. | ANDA | Current |
| 71247-154 | Haloperidol | Haloperidol | Innogenix, Inc. | ANDA | Current |
| 71247-155 | Haloperidol | Haloperidol | Innogenix, Inc. | ANDA | Current |
| 71247-155 | Haloperidol | Haloperidol | Innogenix, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 53954 | ORIG | 2018-05-01 |