Home Applications 219323 Application 219323
Type ANDA
Sponsor ALKEM LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MIRABEGRON MIRABEGRON FOR SUSPENSION, EXTENDED RELEASE;ORAL 8MG/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 A219323-001 MIRABEGRON MIRABEGRON 8MG/ML FOR SUSPENSION, EXTENDED RELEASE / ORAL AB 2026-01-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219323-001 AB
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 2026-02-19 14:30 UTC 2026-02 A219323-001 MIRABEGRON 8MG/ML FOR SUSPENSION, EXTENDED RELEASE / ORAL AB 2026-01-20 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219323-001 MIRABEGRON 8MG/ML FOR SUSPENSION, EXTENDED RELEASE / ORAL AB 2026-01-20 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A219323-001 AB 1 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219323-001 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.
Documents# Document, Submission type, Date table Document Submission type Date 84989 ORIG 2026-02-11