Home Applications 215362 Application 215362
Type ANDA
Sponsor MSN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BUMETANIDE BUMETANIDE TABLET;ORAL 0.5MG No No 002 BUMETANIDE BUMETANIDE TABLET;ORAL 1MG No No 003 BUMETANIDE BUMETANIDE TABLET;ORAL 2MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A215362-001 BUMETANIDE BUMETANIDE 0.5MG TABLET / ORAL AB 2026-02-05 A215362-002 BUMETANIDE BUMETANIDE 1MG TABLET / ORAL AB 2026-02-05 A215362-003 BUMETANIDE BUMETANIDE 2MG TABLET / ORAL AB 2026-02-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 2026-09-14 22:38:34 2026-08 A215362-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2026-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215362-002 BUMETANIDE 1MG TABLET / ORAL AB 2026-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215362-003 BUMETANIDE 2MG TABLET / ORAL AB 2026-02-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215362-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2026-02-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215362-002 BUMETANIDE 1MG TABLET / ORAL AB 2026-02-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215362-003 BUMETANIDE 2MG TABLET / ORAL AB 2026-02-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215362-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2026-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215362-002 BUMETANIDE 1MG TABLET / ORAL AB 2026-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215362-003 BUMETANIDE 2MG TABLET / ORAL AB 2026-02-05 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215362-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2026-02-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215362-002 BUMETANIDE 1MG TABLET / ORAL AB 2026-02-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215362-003 BUMETANIDE 2MG TABLET / ORAL AB 2026-02-05 a50c72e98297…
Observed Orange Book normalized TE history# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bumetanide BUMETANIDE Novadoz Pharmaceuticals LLC cddd33fb-25b0-49ca-ab32-7c79a9b3a384 2026-02-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215362 application number: ANDA215362
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.