Home Applications 012380 Application 012380
Type NDA
Sponsor PARKE DAVIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZARONTIN ETHOSUXIMIDE CAPSULE;ORAL 250MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N012380-001 ZARONTIN ETHOSUXIMIDE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N012380-001 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.
Product history page 2 of 2 · 44 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 N012380-001 ZARONTIN 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N012380-001 ZARONTIN 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N012380-001 ZARONTIN 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N012380-001 ZARONTIN 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0071-0237 Zarontin Ethosuximide Parke-Davis Div of Pfizer Inc NDA Current 0071-0237 Zarontin Ethosuximide Parke-Davis Div of Pfizer Inc NDA Current 59762-2250 Ethosuximide Ethosuximide Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-2250 Ethosuximide Ethosuximide Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-2250 Ethosuximide Ethosuximide Greenstone LLC NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 69167 SUPPL 2021-10-29 69161 SUPPL 2021-10-29 33085 SUPPL 2016-05-20 330 SUPPL 2016-05-20 329 SUPPL 2012-05-09 43585 SUPPL 2012-05-07 10808 SUPPL 2012-05-07 328 SUPPL 2011-06-17 10807 SUPPL 2010-09-20 327 SUPPL 2010-09-20 12012 SUPPL 2009-04-29 33084 SUPPL 2009-04-28 326 SUPPL 2006-09-18 12011 SUPPL 2002-04-19 12010 SUPPL 2001-04-09 12009 SUPPL 2001-04-09 325 SUPPL 2001-04-09