Home Applications 019853 Application 019853
Type NDA
Sponsor VALEANT PHARMS INTL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CUPRIMINE PENICILLAMINE CAPSULE;ORAL 250MG Yes Yes 002 CUPRIMINE PENICILLAMINE CAPSULE;ORAL 125MG 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 N019853-001 CUPRIMINE PENICILLAMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 N019853-002 CUPRIMINE PENICILLAMINE 125MG CAPSULE / ORAL 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 N019853-001 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 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 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL 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 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 25010-705 Cuprimine penicillamine Bausch Health Americas Inc. NDA Current 25010-705 Cuprimine penicillamine Bausch Health US, LLC NDA Current 25010-705 Cuprimine penicillamine Bausch Health US, LLC NDA Current 25010-705 Cuprimine penicillamine Bausch Health US, LLC NDA Current 25010-705 Cuprimine penicillamine Bausch Health Americas Inc. NDA Current 25010-705 Cuprimine penicillamine Bausch Health US, LLC NDA Current 25010-705 Cuprimine penicillamine Aton Pharma, Inc. NDA Current 68682-020 penicillamine penicillamine Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-020 penicillamine penicillamine Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-020 penicillamine penicillamine Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-020 Cuprimine penicillamine Oceanside Pharmaceuticals, Inc. NDA Current 68682-020 penicillamine penicillamine Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-020 penicillamine penicillamine Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-020 penicillamine penicillamine Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 52732 SUPPL 2018-02-27 52731 SUPPL 2018-02-27 11782 SUPPL 2004-11-01 11781 SUPPL 2004-11-01 19762 SUPPL 2004-10-29 1714 SUPPL 2004-10-29 19760 SUPPL 2003-11-25 1713 SUPPL 2003-11-25 34036 SUPPL 2003-06-08 19761 SUPPL 2003-06-08