Is Aggrastat still available?

Yes. Aggrastat (NDA 020913) is listed with marketing status Prescription in the FDA Orange Book.

Does Aggrastat have a generic?

Yes. The Orange Book lists 3 approved generic (ANDA) applications sharing Aggrastat's active ingredient (Tirofiban Hydrochloride). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What does Aggrastat's TE code AP mean?

AP is an "A"-rated therapeutic-equivalence code, meaning the FDA considers Aggrastat substitutable for its reference brand with no expected difference in clinical effect.

What is Aggrastat's FDA application number?

Aggrastat is approved under NDA 020913, held by Medicure.

Orange Book product · Brand (NDA)

Aggrastat

Tirofiban Hydrochloride

Brand (NDA)NDA 020913TE APRLD Medicure

Approved

May 17, 2002

Application

Brand (NDA)

TE code

Listed patents

Aggrastat (Tirofiban Hydrochloride) is Medicure's brand-name drug, approved by the FDA under NDA 020913 in 2002. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its therapeutic-equivalence code is AP, so the FDA considers it substitutable for the reference brand. 3 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.
May 17, 2002
24 yr 6 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

TIROFIBAN HYDROCHLORIDE

Strength

EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Application

NDA 020913

Product number

002

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Same application

Other strengths in NDA 020913

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Tirofiban Hydrochloride 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.

Aggrastat — 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 Tirofiban Hydrochloride active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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