Is Aminocaproic Acid still available?

Aminocaproic Acid (NDA 018590) is listed as Discontinued in the FDA Orange Book — it is no longer marketed. A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.

Does Aminocaproic Acid have a generic?

Yes. The Orange Book lists 26 approved generic (ANDA) applications sharing Aminocaproic Acid's active ingredient (Aminocaproic Acid). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What is Aminocaproic Acid's FDA application number?

Aminocaproic Acid is approved under NDA 018590, held by Baxter Hlthcare.

Orange Book product · Brand (NDA)

Aminocaproic Acid

Brand (NDA)NDA 018590Discontinued Baxter Hlthcare

Approved

Oct 29, 1982

Application

Brand (NDA)

TE code

Not listed

Listed patents

Aminocaproic Acid (Aminocaproic Acid) is Baxter Hlthcare's brand-name drug, approved by the FDA under NDA 018590 in 1982. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 26 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Oct 29, 1982
44 yr 4 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

AMINOCAPROIC ACID

Strength

250MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 018590

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Reference standard (RS)

Brand + generics

Active-ingredient family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

View full Aminocaproic Acid family

Orange Book patent file

Listed patents

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.

Aminocaproic Acid — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Aminocaproic Acid active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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