Application 010571
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COMPAZINE | PROCHLORPERAZINE MALEATE | TABLET;ORAL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | COMPAZINE | PROCHLORPERAZINE MALEATE | TABLET;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | COMPAZINE | PROCHLORPERAZINE MALEATE | TABLET;ORAL | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N010571-001 | COMPAZINE | PROCHLORPERAZINE MALEATE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N010571-002 | COMPAZINE | PROCHLORPERAZINE MALEATE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N010571-003 | COMPAZINE | PROCHLORPERAZINE MALEATE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N010571-001 | COMPAZINE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N010571-002 | COMPAZINE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N010571-003 | COMPAZINE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N010571-001 | COMPAZINE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N010571-002 | COMPAZINE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N010571-003 | COMPAZINE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N010571-001 | COMPAZINE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N010571-002 | COMPAZINE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N010571-003 | COMPAZINE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010571-001 | COMPAZINE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010571-002 | COMPAZINE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010571-003 | COMPAZINE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N010571-001 | COMPAZINE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N010571-002 | COMPAZINE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N010571-003 | COMPAZINE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010571-001 | COMPAZINE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010571-002 | COMPAZINE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010571-003 | COMPAZINE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010571-001 | COMPAZINE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010571-002 | COMPAZINE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010571-003 | COMPAZINE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010571-001 | COMPAZINE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010571-002 | COMPAZINE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010571-003 | COMPAZINE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010571-001 | COMPAZINE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010571-002 | COMPAZINE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010571-003 | COMPAZINE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010571-001 | COMPAZINE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010571-002 | COMPAZINE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010571-003 | COMPAZINE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010571-001 | COMPAZINE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010571-002 | COMPAZINE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010571-003 | COMPAZINE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N010571-001 | COMPAZINE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N010571-002 | COMPAZINE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N010571-003 | COMPAZINE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010571-001 | COMPAZINE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010571-002 | COMPAZINE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010571-003 | COMPAZINE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010571-001 | COMPAZINE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | Cardinal Health 107, LLC | 45f56f93-50a7-4cd3-bce2-f97a80556651 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | A-S Medication Solutions | f387b07a-2d99-4fd5-bcd1-8f04e69b8a39 | 2025-12-03 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | Redpharm Drug | 3dd03606-1f58-43ac-e063-6294a90a4439 | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| Prochlorperazine Maleate | PROCHLORPERAZINE MALEATE | Ajanta Pharma USA Inc. | 9ab78746-b302-4836-95f3-343799929c0e | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | AvPAK | 86ac7223-b840-bc0c-e053-2991aa0a32f2 | 2025-10-28 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| prochlorperazine maleate | PROCHLORPERAZINE MALEATE | Aurobindo Pharma Limited | 7ec4df20-9ea5-4a68-a43f-5ded4eaed235 | 2025-09-11 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | Leading Pharma, LLC | c93494ef-c510-4e46-a1b1-362624200223 | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | Bryant Ranch Prepack | a826f111-4186-47d3-99c1-a72d75776c4c | 2025-05-14 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | Redpharm Drug | 18988af8-545a-3b69-e063-6394a90ae074 | 2025-04-09 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | Bryant Ranch Prepack | 3ccd11d3-5e5e-4ed8-9b0c-49b0a84535ab | 2025-03-24 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | Bionpharma Inc. | 052d351a-978b-6fc3-e063-6294a90aef55 | 2025-03-05 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| Prochlorperazine Maleate | PROCHLORPERAZINE MALEATE | Northstar Rx LLC | 04bf8a16-218a-c648-e063-6294a90a1afb | 2025-02-11 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | Bionpharma Inc. | 2cf363d6-b9e4-2c22-e063-6394a90a7649 | 2025-01-30 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| Prochlorperazine Maleate | PROCHLORPERAZINE MALEATE | Direct_Rx | 02069e43-5245-20dc-e063-6294a90a9dcd | 2025-01-22 | Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| Prochlorperazine Maleate | PROCHLORPERAZINE MALEATE | Zydus Lifesciences Limited | 1e7fd1f5-c9cc-45a2-8974-4e0ceab8406c | 2024-11-15 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| Prochlorperazine Maleate | PROCHLORPERAZINE MALEATE | Zydus Pharmaceuticals (USA) Inc. | d4a34138-a01b-418f-8e0f-e81f6e1cfd89 | 2024-11-15 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | Bryant Ranch Prepack | 664da979-a480-4482-a5a5-0ec98d4c0037 | 2024-08-30 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | NuCare Pharmaceuticals, Inc. | 40bd3a0c-368f-64e9-e054-00144ff88e88 | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | A-S Medication Solutions | 86102abe-0b72-4352-95ce-db88d2e14002 | 2024-05-07 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| Prochlorperazine Maleate | PROCHLORPERAZINE MALEATE | Chartwell RX, LLC | 91adec24-fac8-4a56-b2c3-ae4bbc1160bf | 2024-04-17 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.