Home Applications 018894 Application 018894
Type NDA
Sponsor COSETTE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TOLAZAMIDE TOLAZAMIDE TABLET;ORAL 100MG No No 002 TOLAZAMIDE TOLAZAMIDE TABLET;ORAL 250MG No No 003 TOLAZAMIDE TOLAZAMIDE TABLET;ORAL 500MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018894-001 TOLAZAMIDE TOLAZAMIDE 100MG TABLET / ORAL 1984-11-02 N018894-002 TOLAZAMIDE TOLAZAMIDE 250MG TABLET / ORAL 1984-11-02 N018894-003 TOLAZAMIDE TOLAZAMIDE 500MG TABLET / ORAL 1984-11-02
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 N018894-001 TOLAZAMIDE 100MG TABLET / ORAL 1984-11-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N018894-002 TOLAZAMIDE 250MG TABLET / ORAL 1984-11-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N018894-003 TOLAZAMIDE 500MG TABLET / ORAL 1984-11-02 a50c72e98297…