Home Applications 010841 Application 010841
Type NDA
Sponsor RECORDATI RARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PEGANONE ETHOTOIN TABLET;ORAL 250MG Yes Yes 003 PEGANONE ETHOTOIN TABLET;ORAL 500MG No No
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 N010841-001 PEGANONE ETHOTOIN 250MG TABLET / ORAL RLD, Approved before 1982 N010841-003 PEGANONE ETHOTOIN 500MG TABLET / ORAL Approved before 1982
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 N010841-001 PEGANONE 250MG TABLET / ORAL RLD, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N010841-003 PEGANONE 500MG TABLET / ORAL Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N010841-001 PEGANONE 250MG TABLET / ORAL RLD, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N010841-003 PEGANONE 500MG TABLET / ORAL Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N010841-001 PEGANONE 250MG TABLET / ORAL RLD, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N010841-003 PEGANONE 500MG TABLET / ORAL Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N010841-001 PEGANONE 250MG TABLET / ORAL RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N010841-003 PEGANONE 500MG TABLET / ORAL Approved before 1982 a50c72e98297…
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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55292-602 Peganone ethotoin RECORDATI RARE DISEASES, INC. NDA Current 55292-602 Peganone ethotoin RECORDATI RARE DISEASES, INC. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 240 SUPPL 2011-06-02 43581 SUPPL 2010-06-24 33031 SUPPL 2010-06-14 11913 SUPPL 2010-06-14 239 SUPPL 2009-04-29 33030 SUPPL 2009-04-28 33029 SUPPL 2007-02-21 238 SUPPL 2007-02-12 11912 SUPPL 2003-10-01 237 SUPPL 2003-10-01