Home Applications 015197 Application 015197
Type NDA
Sponsor CLOVER PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMICAR AMINOCAPROIC ACID TABLET;ORAL 500MG Yes No 002 AMICAR AMINOCAPROIC ACID TABLET;ORAL 1GM Yes 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 N015197-001 AMICAR AMINOCAPROIC ACID 500MG TABLET / ORAL AB RLD, Approved before 1982 N015197-002 AMICAR AMINOCAPROIC ACID 1GM TABLET / ORAL AB RLD 2004-06-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 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 · 17 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 17478-768 Aminocaproic Acid Aminocaproic Acid Akorn Operating Company LLC NDA AUTHORIZED GENERIC Current 17478-768 Aminocaproic Acid Aminocaproic Acid Akorn Inc. NDA AUTHORIZED GENERIC Current 17478-768 Aminocaproic Acid Aminocaproic Acid Akorn Inc. NDA AUTHORIZED GENERIC Current 17478-769 Aminocaproic Acid Aminocaproic Acid Akorn Operating Company LLC NDA AUTHORIZED GENERIC Current 17478-769 Aminocaproic Acid Aminocaproic Acid Akorn Inc. NDA AUTHORIZED GENERIC Current 17478-769 Aminocaproic Acid Aminocaproic Acid Akorn Inc. NDA AUTHORIZED GENERIC Current 49411-050 AMICAR Aminocaproic Acid Akorn Operating Company LLC NDA Current 49411-050 AMICAR Aminocaproic Acid Clover Pharmaceuticals Corp. NDA Current 49411-050 AMICAR Aminocaproic Acid Clover Pharmaceuticals Corp. NDA Current 49411-050 AMICAR Aminocaproic Acid Akorn Operating Company LLC NDA Current 49411-051 AMICAR Aminocaproic Acid Akorn Operating Company LLC NDA Current 49411-051 AMICAR Aminocaproic Acid Clover Pharmaceuticals Corp. NDA Current 49411-051 AMICAR Aminocaproic Acid Clover Pharmaceuticals Corp. NDA Current 49411-051 AMICAR Aminocaproic Acid Akorn Operating Company LLC NDA Current 61748-046 Aminocaproic Acid Aminocaproic Acid VersaPharm Inc - an Akorn Company NDA AUTHORIZED GENERIC Current 61748-046 Aminocaproic Acid Aminocaproic Acid Versapharm Incorporated NDA AUTHORIZED GENERIC Current 68151-3023 AMICAR Aminocaproic Acid Carilion Materials Management NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 10856 SUPPL 2008-08-26 12079 SUPPL 2008-08-22 12078 SUPPL 2004-08-25 33133 SUPPL 2004-06-25 33132 SUPPL 2004-06-25 33131 SUPPL 2004-06-25 12077 SUPPL 2004-06-25 10855 SUPPL 2004-06-25 397 SUPPL 2004-06-25 396 SUPPL 2004-06-25 395 SUPPL 2004-06-25