Home Applications 218303 Application 218303
Type ANDA
Sponsor MICRO LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 5MG No No 002 BISOPROLOL FUMARATE BISOPROLOL FUMARATE TABLET;ORAL 10MG 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 A218303-001 BISOPROLOL FUMARATE BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2026-03-09 A218303-002 BISOPROLOL FUMARATE BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2026-03-09
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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218303-001 BISOPROLOL FUMARATE 5MG TABLET / ORAL AB 2026-03-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218303-002 BISOPROLOL FUMARATE 10MG TABLET / ORAL AB 2026-03-09 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218303-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218303-002 AB 1 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 · 1 matching rows.