Home Applications 015230 Application 015230
Type NDA
Sponsor CLOVER PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 AMICAR AMINOCAPROIC ACID SYRUP;ORAL 1.25GM/5ML Yes Yes
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 N015230-002 AMICAR AMINOCAPROIC ACID 0.25GM/ML SOLUTION / ORAL AA 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 N015230-002 AA
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 N015230-002 AMICAR 0.25GM/ML SOLUTION / ORAL AA RLD, RS, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N015230-002 AMICAR 0.25GM/ML SOLUTION / ORAL AA RLD, RS, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N015230-002 AMICAR 0.25GM/ML SOLUTION / ORAL AA RLD, RS, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N015230-002 AMICAR 0.25GM/ML SOLUTION / ORAL AA RLD, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# 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 17478-447 Aminocaproic Acid Aminocaproic Acid Akorn Operating Company LLC NDA AUTHORIZED GENERIC Current 17478-447 Aminocaproic Acid Aminocaproic Acid Akorn Inc. NDA AUTHORIZED GENERIC Current 17478-447 Aminocaproic Acid Aminocaproic Acid Akorn Inc. NDA AUTHORIZED GENERIC Current 49411-052 AMICAR Aminocaproic Acid Akorn Operating Company LLC NDA Current 49411-052 AMICAR Aminocaproic Acid Clover Pharmaceuticals Corp. NDA Current 49411-052 AMICAR Aminocaproic Acid Clover Pharmaceuticals Corp. NDA Current 49411-052 AMICAR Aminocaproic Acid Akorn Operating Company LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 12957 SUPPL 2009-02-13 10858 SUPPL 2009-02-04 10857 SUPPL 2008-08-26 400 SUPPL 2008-08-22 399 SUPPL 2004-08-25 12956 SUPPL 2003-09-09 12955 SUPPL 2003-09-09 398 SUPPL 2003-09-09