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Data updated: Mar 10, 2026

AMINOCAPROIC ACID IN PLASTIC CONTAINER

AMINOCAPROIC ACID
Oncology Approved 1987-03-09
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
39
Years on Market

Details

Status
Prescription
First Approved
1987-03-09
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Pfizer
Active Ingredient: AMINOCAPROIC ACID

AMINOCAPROIC ACID IN PLASTIC CONTAINER Approval History

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What AMINOCAPROIC ACID IN PLASTIC CONTAINER Treats

9 indications

AMINOCAPROIC ACID IN PLASTIC CONTAINER is approved for 9 conditions since its original approval in 1987. 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

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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 IN PLASTIC CONTAINER FDA Label Details

Pro

Indications & Usage

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: ANDA070010 → Label: DailyMed → Trials: ClinicalTrials.gov →

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