Home Applications 009170 Application 009170
Type NDA
Sponsor VALEANT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 MYSOLINE PRIMIDONE TABLET;ORAL 250MG Yes No 003 MYSOLINE PRIMIDONE TABLET;ORAL 50MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N009170-002 MYSOLINE PRIMIDONE 250MG TABLET / ORAL AB RLD, Approved before 1982 N009170-003 MYSOLINE PRIMIDONE 50MG TABLET / ORAL AB RLD, RS, Approved before 1982
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.
Product history page 3 of 3 · 88 observed 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 2022-10-28 04:53 UTC 2022-10 N009170-002 MYSOLINE 250MG TABLET / ORAL AB RLD, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N009170-003 MYSOLINE 50MG TABLET / ORAL AB RLD, RS, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N009170-002 MYSOLINE 250MG TABLET / ORAL AB RLD, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N009170-003 MYSOLINE 50MG TABLET / ORAL AB RLD, RS, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N009170-002 MYSOLINE 250MG TABLET / ORAL AB RLD, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N009170-003 MYSOLINE 50MG TABLET / ORAL AB RLD, RS, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N009170-002 MYSOLINE 250MG TABLET / ORAL AB RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N009170-003 MYSOLINE 50MG TABLET / ORAL AB RLD, RS, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66490-690 Mysoline Primidone Valeant Pharmaceuticals North America NDA Current 66490-690 Mysoline Primidone Bausch Health US, LLC NDA Current 66490-690 Mysoline Primidone Bausch Health US, LLC NDA Current 66490-690 Mysoline Primidone Bausch Health US, LLC NDA Current 66490-690 Mysoline Primidone Bausch Health US, LLC NDA Current 66490-691 Mysoline Primidone Valeant Pharmaceuticals North America NDA Current 66490-691 Mysoline Primidone Bausch Health US, LLC NDA Current 66490-691 Mysoline Primidone Bausch Health US, LLC NDA Current 66490-691 Mysoline Primidone Bausch Health US, LLC NDA Current 66490-691 Mysoline Primidone Bausch Health US, LLC NDA Current 68682-690 Primidone Primidone Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-690 Primidone Primidone Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-691 Primidone Primidone Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-691 Primidone Primidone Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 64846 SUPPL 2020-10-06 64845 SUPPL 2020-10-06 64818 SUPPL 2020-10-05 11866 SUPPL 2011-08-12 23090 SUPPL 2010-07-30 10719 SUPPL 2010-07-30 129 SUPPL 2010-07-23 32987 SUPPL 2009-10-15 32988 SUPPL 2009-05-13 128 SUPPL 2009-05-13 11865 SUPPL 2009-05-01 127 SUPPL 2009-02-03 11864 SUPPL 2008-06-16