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 2 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 2019-12-13 00:20 UTC 2019-12 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019853-001 CUPRIMINE 250MG CAPSULE / ORAL AB RLD, RS, Approved before 1982 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019853-002 CUPRIMINE 125MG CAPSULE / ORAL Approved before 1982 3a93d1ddd44b…
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