Application 089893
- Type
- ANDA
- Sponsor
- QUAD PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRIFLUOPERAZINE HCL | TRIFLUOPERAZINE HYDROCHLORIDE | Injectable; Injection | EQ 2MG BASE/ML | No | No |
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.