Home Applications 216988 Application 216988
Type ANDA
Sponsor RUBICON RESEARCH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLONAZEPAM CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 0.125MG No No 002 CLONAZEPAM CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 0.25MG No No 003 CLONAZEPAM CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 0.5MG No No 004 CLONAZEPAM CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 1MG No No 005 CLONAZEPAM CLONAZEPAM TABLET, ORALLY DISINTEGRATING;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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216988-001 CLONAZEPAM CLONAZEPAM 0.125MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 A216988-002 CLONAZEPAM CLONAZEPAM 0.25MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 A216988-003 CLONAZEPAM CLONAZEPAM 0.5MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 A216988-004 CLONAZEPAM CLONAZEPAM 1MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 A216988-005 CLONAZEPAM CLONAZEPAM 2MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 A216988-001 CLONAZEPAM 0.125MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216988-002 CLONAZEPAM 0.25MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216988-003 CLONAZEPAM 0.5MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216988-004 CLONAZEPAM 1MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216988-005 CLONAZEPAM 2MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-05-21 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 A216988-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216988-002 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216988-003 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216988-004 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216988-005 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join clonazepam CLONAZEPAM Advagen Pharma Ltd 19fc756c-72fe-4504-beaa-4fa2235af18c 2026-05-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216988 application number: ANDA216988