Home Applications 010653 Application 010653
Type NDA
Sponsor 3M Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DISIPAL ORPHENADRINE HYDROCHLORIDE TABLET;ORAL 50MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N010653-001 DISIPAL ORPHENADRINE HYDROCHLORIDE 50MG TABLET / ORAL 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.
Product history page 2 of 2 · 42 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 2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N010653-001 DISIPAL 50MG TABLET / ORAL Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N010653-001 DISIPAL 50MG TABLET / ORAL Approved before 1982 a50c72e98297…