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Data updated: Mar 10, 2026

AMINOCAPROIC ACID

AMINOCAPROIC ACID
Oncology Approved 1982-10-29
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
25
Indications
--
Phase 3 Trials
43
Years on Market

Details

Status
Prescription
First Approved
1982-10-29
Routes
ORAL, INJECTION, Injection
Dosage Forms
SOLUTION, TABLET, INJECTABLE, Injectable

Companies

CARNEGIE TARO AMNEAL PHARMOBEDIENT MSN Aurobindo Pharma Pfizer EPIC PHARMA LLC Baxter SUNNY GEN ILAC REGCON HOLDINGS ANI PHARMS TP ANDA HOLDINGS SCIEGEN PHARMS AJENAT PHARMS SOMERSET THERAPS LLC LUITPOLD ADAPTIS VISTAPHARM LLC ANNORA PHARMA ABRAXIS PHARM QUAD PHARMS
Active Ingredient: AMINOCAPROIC ACID

AMINOCAPROIC ACID Approval History

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What AMINOCAPROIC ACID Treats

9 indications

AMINOCAPROIC ACID is approved for 9 conditions since its original approval in 1982. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Fibrinolysis
  • Aplastic Anemia
  • Abruptio Placentae
  • Hepatic Cirrhosis
  • Prostate Cancer
  • Lung Cancer
  • Stomach Cancer
  • Cervical Cancer
Source: FDA Label

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

AMINOCAPROIC ACID FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

Aminocaproic Acid Injection is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, fresh whole blood transfusions, fibrinogen infusions, and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures), and portacaval shunt; hematological disorders such as aplastic anemia; acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and c...

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Data Sources

FDA Approval: ANDA214140 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.