Home Applications 088969 Application 088969
Type ANDA
Sponsor DURAMED PHARMS BARR Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRIFLUOPERAZINE HYDROCHLORIDE TRIFLUOPERAZINE HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A088969-001 TRIFLUOPERAZINE HYDROCHLORIDE TRIFLUOPERAZINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 1985-04-23
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.
Product history page 2 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-09-29 23:25 UTC 2022-09 A088969-001 TRIFLUOPERAZINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 1985-04-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088969-001 TRIFLUOPERAZINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 1985-04-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A088969-001 TRIFLUOPERAZINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 1985-04-23 a50c72e98297…
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.
Matched openFDA labels page 1 of 1 · 11 matching rows.
Brand, Generic, Manufacturer table 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 Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE Trifluoperazine Hydrochloride TRIFLUOPERAZINE HYDROCHLORIDE Safecor Health LLC 8501543b-0c74-4087-9946-e7198400814a 2026-05-04 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE Trifluoperazine Hydrochloride TRIFLUOPERAZINE HYDROCHLORIDE REMEDYREPACK INC. 339ceb53-3b1c-459f-84eb-77bd4315c998 2026-01-30 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE Trifluoperazine Hydrochloride TRIFLUOPERAZINE HYDROCHLORIDE REMEDYREPACK INC. 6a05900b-ca43-483a-a460-8ac378653f12 2026-01-30 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE Trifluoperazine Hydrochloride TRIFLUOPERAZINE HYDROCHLORIDE Mylan Institutional Inc. f742a579-411a-4140-91c4-edc735d638fa 2025-07-22 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE Trifluoperazine Hydrochloride TRIFLUOPERAZINE HYDROCHLORIDE Mylan Pharmaceuticals Inc. c2575a86-19e5-44df-8603-ff066bb9c9c5 2025-01-15 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE Trifluoperazine Hydrochloride TRIFLUOPERAZINE HYDROCHLORIDE Sandoz Inc. ae43c10e-cfa9-4298-8af5-7a3e6524bbda 2024-11-30 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE Trifluoperazine Hydrochloride TRIFLUOPERAZINE HYDROCHLORIDE Bryant Ranch Prepack e63617bb-8186-43d3-9d01-aa53217343e4 2024-10-17 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE Trifluoperazine Hydrochloride TRIFLUOPERAZINE HYDROCHLORIDE Bryant Ranch Prepack 19b76401-6790-44f7-b756-b078948bbf12 2024-04-02 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE Trifluoperazine Hydrochloride TRIFLUOPERAZINE HYDROCHLORIDE Bryant Ranch Prepack 7be0a6fa-a2a0-4f9d-94ca-47ab51de9c1d 2024-04-02 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE Trifluoperazine Hydrochloride TRIFLUOPERAZINE HYDROCHLORIDE Bryant Ranch Prepack df3e0bef-1032-405d-bd18-f65c27af94eb 2024-04-02 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.