Application 011552
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | TABLET;ORAL | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | TABLET;ORAL | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | TABLET;ORAL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 006 | STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | CONCENTRATE;ORAL | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N011552-001 | STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011552-002 | STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011552-003 | STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011552-004 | STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011552-005 | STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N011552-006 | STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CONCENTRATE / 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011552-005 | STELAZINE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011552-006 | STELAZINE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CONCENTRATE / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011552-001 | STELAZINE | EQ 1MG 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 | N011552-002 | STELAZINE | EQ 2MG 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 | N011552-003 | STELAZINE | 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 | N011552-004 | STELAZINE | 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 | N011552-005 | STELAZINE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011552-006 | STELAZINE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CONCENTRATE / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011552-001 | STELAZINE | EQ 1MG 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 | N011552-002 | STELAZINE | EQ 2MG 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 | N011552-003 | STELAZINE | 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 | N011552-004 | STELAZINE | 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 | N011552-005 | STELAZINE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011552-006 | STELAZINE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CONCENTRATE / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011552-001 | STELAZINE | EQ 1MG 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 | N011552-002 | STELAZINE | EQ 2MG 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 | N011552-003 | STELAZINE | 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 | N011552-004 | STELAZINE | 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 | N011552-005 | STELAZINE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011552-006 | STELAZINE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CONCENTRATE / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011552-001 | STELAZINE | EQ 1MG 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 | N011552-002 | STELAZINE | EQ 2MG 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 | N011552-003 | STELAZINE | 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 | N011552-004 | STELAZINE | 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 | N011552-005 | STELAZINE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011552-006 | STELAZINE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CONCENTRATE / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011552-001 | STELAZINE | EQ 1MG 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 | N011552-002 | STELAZINE | EQ 2MG 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 | N011552-003 | STELAZINE | 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 | N011552-004 | STELAZINE | 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 | N011552-005 | STELAZINE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011552-006 | STELAZINE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CONCENTRATE / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011552-001 | STELAZINE | EQ 1MG 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 | N011552-002 | STELAZINE | EQ 2MG 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 | N011552-003 | STELAZINE | 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 | N011552-004 | STELAZINE | 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 | N011552-005 | STELAZINE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011552-006 | STELAZINE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CONCENTRATE / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011552-001 | STELAZINE | EQ 1MG 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 | N011552-002 | STELAZINE | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… |
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 |
|---|---|---|---|---|---|---|
| Trifluoperazine Hydrochloride | TRIFLUOPERAZINE HYDROCHLORIDE | REMEDYREPACK INC. | f789e8f4-7ed2-4cac-b1b1-5068690cd0ed | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | TRIFLUOPERAZINE HYDROCHLORIDE |
| Trifluoperazine Hydrochloride | TRIFLUOPERAZINE HYDROCHLORIDE | Safecor Health LLC | 8501543b-0c74-4087-9946-e7198400814a | 2026-05-04 | Boxed warning, Warnings, Adverse reactions | TRIFLUOPERAZINE HYDROCHLORIDE |
| Trifluoperazine Hydrochloride | TRIFLUOPERAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 339ceb53-3b1c-459f-84eb-77bd4315c998 | 2026-01-30 | Boxed warning, Warnings, Adverse reactions | TRIFLUOPERAZINE HYDROCHLORIDE |
| Trifluoperazine Hydrochloride | TRIFLUOPERAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 6a05900b-ca43-483a-a460-8ac378653f12 | 2026-01-30 | Boxed warning, Warnings, Adverse reactions | TRIFLUOPERAZINE HYDROCHLORIDE |
| Trifluoperazine Hydrochloride | TRIFLUOPERAZINE HYDROCHLORIDE | Mylan Institutional Inc. | f742a579-411a-4140-91c4-edc735d638fa | 2025-07-22 | Boxed warning, Warnings, Adverse reactions | TRIFLUOPERAZINE HYDROCHLORIDE |
| Trifluoperazine Hydrochloride | TRIFLUOPERAZINE HYDROCHLORIDE | Mylan Pharmaceuticals Inc. | c2575a86-19e5-44df-8603-ff066bb9c9c5 | 2025-01-15 | Boxed warning, Warnings, Adverse reactions | TRIFLUOPERAZINE HYDROCHLORIDE |
| Trifluoperazine Hydrochloride | TRIFLUOPERAZINE HYDROCHLORIDE | Sandoz Inc. | ae43c10e-cfa9-4298-8af5-7a3e6524bbda | 2024-11-30 | Boxed warning, Warnings, Adverse reactions | TRIFLUOPERAZINE HYDROCHLORIDE |
| Trifluoperazine Hydrochloride | TRIFLUOPERAZINE HYDROCHLORIDE | Bryant Ranch Prepack | e63617bb-8186-43d3-9d01-aa53217343e4 | 2024-10-17 | Boxed warning, Warnings, Adverse reactions | TRIFLUOPERAZINE HYDROCHLORIDE |
| Trifluoperazine Hydrochloride | TRIFLUOPERAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 19b76401-6790-44f7-b756-b078948bbf12 | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | TRIFLUOPERAZINE HYDROCHLORIDE |
| Trifluoperazine Hydrochloride | TRIFLUOPERAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 7be0a6fa-a2a0-4f9d-94ca-47ab51de9c1d | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | TRIFLUOPERAZINE HYDROCHLORIDE |
| Trifluoperazine Hydrochloride | TRIFLUOPERAZINE HYDROCHLORIDE | Bryant Ranch Prepack | df3e0bef-1032-405d-bd18-f65c27af94eb | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | TRIFLUOPERAZINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.