Orange Book product · Brand (NDA)

BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

BIVALIRUDIN

Brand (NDA)NDA 208374DISCN BAXTER HLTHCARE CORP

View BIVALIRUDIN family Open on FDA Orange Book

At a glance

Dec 21, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Dec 21, 2017
8 yr 7 mo ago
Today

Pharmaceutical detail

Active ingredient

BIVALIRUDIN

Strength

250MG/50ML (5MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 208374

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

View full family

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

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.

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