FDA Orange Book · active-ingredient family
Aminocaproic acid
Aminocaproic acid: 4 brands, 26 generics; first approved Oct 29, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 26 ANDA applications approved.
Brands (NDA)
4
Generics (ANDA)
26
Listed patents
0
Presentations
35
Brand (NDA) products
Originator applications
- AMICARRLDHIKMANDA 01519720042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - AMICARRLDEPIC PHARMA LLCNDA 015229—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/ML INJECTABLE INJECTION Discontinued — - AMICARRLDHIKMANDA 015230—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25GM/ML SOLUTION ORAL Rx AA - AMINOCAPROIC ACIDBAXTER HLTHCARENDA 0185901982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (26)
Abbreviated applications
- AMINOCAPROIC ACIDZENARAANDA 2153742025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/ML INJECTABLE INJECTION Rx AP - AMINOCAPROIC ACIDSCIEGEN PHARMSANDA 2132162025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25GM/ML SOLUTION ORAL Rx AA - AMINOCAPROIC ACIDMSNANDA 2151002024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25GM/ML SOLUTION ORAL Rx AA - AMINOCAPROIC ACIDSUNNYANDA 2132132023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25GM/ML SOLUTION ORAL Rx AA - AMINOCAPROIC ACIDMSNANDA 21293820232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - AMINOCAPROIC ACIDTAROANDA 2144582023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25GM/ML SOLUTION ORAL Discontinued — - AMINOCAPROIC ACIDANNORA PHARMAANDA 2164642022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25GM/ML SOLUTION ORAL Rx AA - AMINOCAPROIC ACIDAUROBINDO PHARMAANDA 2168042022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25GM/ML SOLUTION ORAL Rx AA - AMINOCAPROIC ACIDRISINGANDA 21394420222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - AMINOCAPROIC ACIDREGCON HOLDINGSANDA 2155102022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25GM/ML SOLUTION ORAL Rx AA - AMINOCAPROIC ACIDADAPTISANDA 2121102021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — - AMINOCAPROIC ACIDAJENAT PHARMSANDA 2138252021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25GM/ML SOLUTION ORAL Rx AA - AMINOCAPROIC ACIDCARNEGIEANDA 21392820212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - AMINOCAPROIC ACIDCARNEGIEANDA 2141402021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25GM/ML SOLUTION ORAL Rx AA - AMINOCAPROIC ACIDANI PHARMSANDA 2116292020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — - AMINOCAPROIC ACIDRSTP ANDA HOLDINGSANDA 2124942020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25GM/ML SOLUTION ORAL Rx AA - AMINOCAPROIC ACIDVISTAPHARM LLCANDA 2128142020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25GM/ML SOLUTION ORAL Discontinued — - AMINOCAPROIC ACIDAMNEALANDA 2124922019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB - AMINOCAPROIC ACIDAMNEALANDA 2127802019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25GM/ML SOLUTION ORAL Rx AA - AMINOCAPROIC ACIDRSSUNNYANDA 20906020182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - HIKMAANDA 0756022001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — - AMINOCAPROIC ACIDEPIC PHARMA LLCANDA 0747591998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25GM/ML SOLUTION ORAL Discontinued — - AMINOCAPROIC ACIDHOSPIRAANDA 0708881988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/ML INJECTABLE INJECTION Discontinued — - AMINOCAPROIC ACIDLUITPOLDANDA 0711921987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/ML INJECTABLE INJECTION Rx AP - HOSPIRAANDA 0700101987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/ML INJECTABLE INJECTION Rx AP - AMINOCAPROIC ACIDABRAXIS PHARMANDA 0705221986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/ML INJECTABLE INJECTION Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
44 yr 5 mo ago
Most recent approval
1 yr ago
Approvals span 1982–2025 across 30 FDA applications.
Brand (NDA) 413%
Generic (ANDA) 2687%
Aminocaproic acid: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
