Application 011000
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COMPAZINE | PROCHLORPERAZINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 10MG BASE | No | No |
| 002 | COMPAZINE | PROCHLORPERAZINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 15MG BASE | No | No |
| 003 | COMPAZINE | PROCHLORPERAZINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 30MG BASE | No | No |
| 004 | COMPAZINE | PROCHLORPERAZINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 75MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N011000-001 | COMPAZINE | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | ||
| N011000-002 | COMPAZINE | PROCHLORPERAZINE MALEATE | EQ 15MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | ||
| N011000-003 | COMPAZINE | PROCHLORPERAZINE MALEATE | EQ 30MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | ||
| N011000-004 | COMPAZINE | PROCHLORPERAZINE MALEATE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011000-001 | COMPAZINE | EQ 10MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011000-002 | COMPAZINE | EQ 15MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011000-003 | COMPAZINE | EQ 30MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011000-004 | COMPAZINE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011000-001 | COMPAZINE | EQ 10MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011000-002 | COMPAZINE | EQ 15MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011000-003 | COMPAZINE | EQ 30MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011000-004 | COMPAZINE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011000-001 | COMPAZINE | EQ 10MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011000-002 | COMPAZINE | EQ 15MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011000-003 | COMPAZINE | EQ 30MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011000-004 | COMPAZINE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011000-001 | COMPAZINE | EQ 10MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011000-002 | COMPAZINE | EQ 15MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011000-003 | COMPAZINE | EQ 30MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011000-004 | COMPAZINE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011000-001 | COMPAZINE | EQ 10MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011000-002 | COMPAZINE | EQ 15MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011000-003 | COMPAZINE | EQ 30MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011000-004 | COMPAZINE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011000-001 | COMPAZINE | EQ 10MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011000-002 | COMPAZINE | EQ 15MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011000-003 | COMPAZINE | EQ 30MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011000-004 | COMPAZINE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N011000-001 | COMPAZINE | EQ 10MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N011000-002 | COMPAZINE | EQ 15MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N011000-003 | COMPAZINE | EQ 30MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N011000-004 | COMPAZINE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011000-001 | COMPAZINE | EQ 10MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011000-002 | COMPAZINE | EQ 15MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011000-003 | COMPAZINE | EQ 30MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011000-004 | COMPAZINE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N011000-001 | COMPAZINE | EQ 10MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N011000-002 | COMPAZINE | EQ 15MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N011000-003 | COMPAZINE | EQ 30MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N011000-004 | COMPAZINE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N011000-001 | COMPAZINE | EQ 10MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N011000-002 | COMPAZINE | EQ 15MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N011000-003 | COMPAZINE | EQ 30MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N011000-004 | COMPAZINE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 4b0b4de00fa7… |
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 | REMEDYREPACK INC. | 851dddc0-26da-48eb-b039-cd85384ce864 | 2026-09-04 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| Prochlorperazine Maleate | PROCHLORPERAZINE MALEATE | REMEDYREPACK INC. | 5c1dd0ea-89e9-4317-a83e-5e15da79ca20 | 2026-08-31 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | Preferred Pharmaceuticals Inc. | f3adc8a4-2c2b-4d5e-803f-38361966cc68 | 2026-08-21 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| prochlorperazine maleate | PROCHLORPERAZINE MALEATE | REMEDYREPACK INC. | b3c1d53b-702a-4980-973f-7f2e3affea70 | 2026-08-19 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| Prochlorperazine Maleate | PROCHLORPERAZINE MALEATE | Major Pharmaceuticals | d6fc83ad-9cce-4e60-854c-3825313ee60c | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | REMEDYREPACK INC. | 5fbf5fc6-a2d9-4e5d-8485-e6e949ca497d | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| Prochlorperazine Maleate | PROCHLORPERAZINE MALEATE | ANI Pharmaceuticals, Inc. | 50ce4381-94ef-49ff-8794-cfde0ee803b4 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | PD-Rx Pharmaceuticals, Inc. | fc77a504-4642-47c1-b2e3-c5db11e5816d | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| prochlorperazine maleate | PROCHLORPERAZINE MALEATE | Amneal Pharmaceuticals NY LLC | a2a48790-0634-4b46-b362-98b7c252836f | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | Bryant Ranch Prepack | 7e3aa80a-3a5f-4937-b5aa-4ce2aa6ece1b | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | A-S Medication Solutions | 8b58b63c-0a75-406b-bb29-acf0a40353bd | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | GLENMARK PHARMACEUTICALS INC., USA | 9c806152-70d0-43eb-b183-b51b12b82b31 | 2026-01-27 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| Prochlorperazine Maleate | PROCHLORPERAZINE MALEATE | Northwind Health Company, LLC | 115a4125-07df-9f9b-e063-6394a90a3e49 | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | Northwind Health Company, LLC | c524a28e-1e08-4aa6-a9f0-0a3280a3c213 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | Northwind Health Company, LLC | f2f12ccc-6e51-0a67-e053-2995a90a22bc | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | Redpharm Drug | 44f278eb-3588-af83-e063-6394a90a73cf | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | QPharma, Inc. | dc692e77-5240-4aa6-8fe9-9ffcbb267261 | 2025-12-19 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | PD-Rx Pharmaceuticals, Inc. | 3b022837-0fcc-d38a-e063-6394a90a0f7f | 2025-12-15 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | Jubilant Cadista Pharmaceuticals Inc. | b05bc20e-cd19-ab40-1ad0-84a115d6d69e | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | Cardinal Health 107, LLC | 45f56f93-50a7-4cd3-bce2-f97a80556651 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE MALEATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 11918 | SUPPL | 2001-04-03 |