Home Applications 088804 Application 088804
Type ANDA
Sponsor HOSPIRA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRIMETHOBENZAMIDE HYDROCHLORIDE TRIMETHOBENZAMIDE HYDROCHLORIDE INJECTABLE;INJECTION 100MG/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A088804-001 TRIMETHOBENZAMIDE HYDROCHLORIDE TRIMETHOBENZAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION 1987-04-03
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 table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A088804-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION 1987-04-03 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 7 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Trimethobenzamide Hydrochloride TRIMETHOBENZAMIDE HYDROCHLORIDE BPI Labs, LLC a9a661ca-87ca-4c96-88ef-58fcaae233b5 2026-07-01 Warnings, Adverse reactions Name fallback brand name: Trimethobenzamide Hydrochloride generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE Tigan TRIMETHOBENZAMIDE HYDROCHLORIDE Par Health USA, LLC 7da90678-b229-4ad6-9193-2b8a3e9ba695 2026-03-10 Warnings, Adverse reactions Name fallback generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE Trimethobenzamide Hydrochloride TRIMETHOBENZAMIDE HYDROCHLORIDE Chartwell RX, LLC ee626da9-cffc-4bb9-a528-482687201b2a 2025-12-11 Warnings, Adverse reactions Name fallback brand name: Trimethobenzamide Hydrochloride generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE Tigan TRIMETHOBENZAMIDE HYDROCHLORIDE Henry Schein, Inc 147def93-cd3d-4e42-89ad-6a6b413bf362 2025-10-14 Warnings, Adverse reactions Name fallback generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE Trimethobenzamide Hydrochloride TRIMETHOBENZAMIDE HYDROCHLORIDE Bryant Ranch Prepack 00ba5395-1455-4ea9-9278-e3749979526c 2024-04-04 Warnings, Adverse reactions Name fallback brand name: Trimethobenzamide Hydrochloride generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE Trimethobenzamide Hydrochloride TRIMETHOBENZAMIDE HYDROCHLORIDE Lupin Pharmaceuticals,Inc. c18073be-d52a-4347-a8d1-6be11bcb7824 2024-01-30 Warnings, Adverse reactions Name fallback brand name: Trimethobenzamide Hydrochloride generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE Trimethobenzamide Hydrochloride TRIMETHOBENZAMIDE HYDROCHLORIDE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. b0aa9b7e-bbe7-482e-81d3-d9658d5ac21f 2023-11-21 Warnings, Adverse reactions Name fallback brand name: Trimethobenzamide Hydrochloride generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE