Orange Book product · Brand (NDA)

FLUDARABINE PHOSPHATE

Brand (NDA)NDA 022137DISCN CAPLIN ONE LABS

View FLUDARABINE PHOSPHATE family Open on FDA Orange Book

At a glance

Sep 21, 2007

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Sep 21, 2007
19 yr ago
Today

Pharmaceutical detail

Active ingredient

FLUDARABINE PHOSPHATE

Strength

50MG/2ML (25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 022137

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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