Home Applications 009053 Application 009053
Type NDA
Sponsor STASON PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 PURINETHOL MERCAPTOPURINE TABLET;ORAL 50MG Yes No
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date N009053-002 PURINETHOL MERCAPTOPURINE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD, Approved before 1982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 N009053-002 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UTC 2022-10 N009053-002 PURINETHOL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N009053-002 PURINETHOL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N009053-002 PURINETHOL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N009053-002 PURINETHOL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD, Approved before 1982 a50c72e98297…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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 60763-601 PURINETHOL Mercaptopurine Stason Pharmaceuticals, Inc. NDA Current 60763-601 PURINETHOL Mercaptopurine Stason Pharmaceuticals, Inc. NDA Current 69076-913 Mercaptopurine Mercaptopurine Quinn Pharmaceuticals NDA AUTHORIZED GENERIC Current 69076-913 Mercaptopurine Mercaptopurine Quinn Pharmaceuticals, LLC NDA AUTHORIZED GENERIC Current 69076-913 Mercaptopurine Mercaptopurine Florida Pharmaceutical Product, LLC. NDA AUTHORIZED GENERIC Current 69076-913 Mercaptopurine Mercaptopurine Florida Pharmaceutical Product, LLC. NDA AUTHORIZED GENERIC Current 69076-913 Mercaptopurine Mercaptopurine Quinn Pharmaceuticals NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 79052 SUPPL 2024-07-12 79036 SUPPL 2024-07-10 65795 SUPPL 2020-12-31 65779 SUPPL 2020-12-30 62800 SUPPL 2020-05-01 62761 SUPPL 2020-04-30 54333 SUPPL 2018-05-24 54317 SUPPL 2018-05-24 10716 SUPPL 2011-05-31 123 SUPPL 2011-05-31 10715 SUPPL 2004-07-21 32983 SUPPL 2003-01-10 174 SUPPL 2003-01-10 122 SUPPL 2002-09-06 121 SUPPL 2002-03-22