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 42 .
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 1 of 3 · 84 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 2026-08-18 06:07:40 2026-07 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N015197-001 AMICAR 500MG TABLET / ORAL RLD, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N015197-002 AMICAR 1GM TABLET / ORAL RLD 2004-06-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N015197-001 AMICAR 500MG TABLET / ORAL RLD, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N015197-002 AMICAR 1GM TABLET / ORAL RLD 2004-06-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N015197-001 AMICAR 500MG TABLET / ORAL RLD, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N015197-002 AMICAR 1GM TABLET / ORAL RLD 2004-06-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N015197-001 AMICAR 500MG TABLET / ORAL RLD, Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N015197-002 AMICAR 1GM TABLET / ORAL RLD 2004-06-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N015197-001 AMICAR 500MG TABLET / ORAL RLD, Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N015197-002 AMICAR 1GM TABLET / ORAL RLD 2004-06-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N015197-001 AMICAR 500MG TABLET / ORAL RLD, Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N015197-002 AMICAR 1GM TABLET / ORAL RLD 2004-06-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N015197-001 AMICAR 500MG TABLET / ORAL RLD, Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N015197-002 AMICAR 1GM TABLET / ORAL RLD 2004-06-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N015197-001 AMICAR 500MG TABLET / ORAL AB RLD, Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N015197-002 AMICAR 1GM TABLET / ORAL AB RLD 2004-06-24 4b0b4de00fa7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 70 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.
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