Application 011127
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COMPAZINE | PROCHLORPERAZINE | SUPPOSITORY;RECTAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | COMPAZINE | PROCHLORPERAZINE | SUPPOSITORY;RECTAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 003 | COMPAZINE | PROCHLORPERAZINE | SUPPOSITORY;RECTAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N011127-001 | COMPAZINE | PROCHLORPERAZINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | ||
| N011127-002 | COMPAZINE | PROCHLORPERAZINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | ||
| N011127-003 | COMPAZINE | PROCHLORPERAZINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 |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| 2026-08 | N011127-001 | COMPAZINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N011127-002 | COMPAZINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N011127-003 | COMPAZINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011127-001 | COMPAZINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011127-002 | COMPAZINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011127-003 | COMPAZINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011127-001 | COMPAZINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011127-002 | COMPAZINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011127-003 | COMPAZINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011127-001 | COMPAZINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011127-002 | COMPAZINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011127-003 | COMPAZINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011127-001 | COMPAZINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011127-002 | COMPAZINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011127-003 | COMPAZINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011127-001 | COMPAZINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011127-002 | COMPAZINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011127-003 | COMPAZINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011127-001 | COMPAZINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011127-002 | COMPAZINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011127-003 | COMPAZINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011127-001 | COMPAZINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011127-002 | COMPAZINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011127-003 | COMPAZINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011127-001 | COMPAZINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011127-002 | COMPAZINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011127-003 | COMPAZINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011127-001 | COMPAZINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011127-002 | COMPAZINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011127-003 | COMPAZINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011127-001 | COMPAZINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011127-002 | COMPAZINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011127-003 | COMPAZINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011127-001 | COMPAZINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011127-002 | COMPAZINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011127-003 | COMPAZINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011127-001 | COMPAZINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011127-002 | COMPAZINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011127-003 | COMPAZINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011127-001 | COMPAZINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / RECTAL | 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 | PROCHLORPERAZINE | Cosette Pharmaceuticals, Inc. | 9595346e-76e5-e155-341b-ffaaafb885ab | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE |
| Compro | PROCHLORPERAZINE | PD-Rx Pharmaceuticals, Inc. | b23b67eb-78b7-48eb-84ff-c95d3ce8683c | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE |
| Compro | PROCHLORPERAZINE | Padagis US LLC | ea381bc5-0957-4c91-826a-0ff680cebacc | 2024-11-20 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE |
| Prochlorperazine | PROCHLORPERAZINE | PharmPak, Inc. | 383744db-ba57-478a-8041-2ecc26d3e1ec | 2022-10-09 | Boxed warning, Warnings, Adverse reactions | PROCHLORPERAZINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 249 | SUPPL | 2001-04-03 |