Home Applications 203409 Application 203409
Type ANDA
Sponsor MACLEODS PHARMS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 1MG No No 002 TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 2MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203409-001 TOLTERODINE TARTRATE TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 A203409-002 TOLTERODINE TARTRATE TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 a50c72e98297…2026-08-01 22:54:32 2026-06 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A203409-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A203409-002 AB 1 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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 33342-097 Tolterodine tartrate Tolterodine tartrate Macleods Pharmaceuticals Limited ANDA Current 33342-097 Tolterodine tartrate Tolterodine tartrate Macleods Pharmaceuticals Limited ANDA Current 33342-097 Tolterodine tartrate Tolterodine tartrate Macleods Pharmaceuticals Limited ANDA Current 33342-097 Tolterodine tartrate Tolterodine tartrate Macleods Pharmaceuticals Limited ANDA Current 33342-098 Tolterodine tartrate Tolterodine tartrate Macleods Pharmaceuticals Limited ANDA Current 33342-098 Tolterodine tartrate Tolterodine tartrate Macleods Pharmaceuticals Limited ANDA Current 33342-098 Tolterodine tartrate Tolterodine tartrate Macleods Pharmaceuticals Limited ANDA Current 33342-098 Tolterodine tartrate Tolterodine tartrate Macleods Pharmaceuticals Limited ANDA Current 70518-2794 Tolterodine tartrate Tolterodine tartrate REMEDYREPACK INC. ANDA Current 70518-2794 Tolterodine tartrate Tolterodine tartrate REMEDYREPACK INC. ANDA Current