Orange Book product · Brand (NDA)

SODIUM FLUORIDE F 18

SODIUM FLUORIDE F-18

Brand (NDA)NDA 022494DISCN NIH NCI DCTD

View SODIUM FLUORIDE F-18 family Open on FDA Orange Book

At a glance

Jan 26, 2011

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jan 26, 2011
15 yr 7 mo ago
Today

Pharmaceutical detail

Active ingredient

SODIUM FLUORIDE F-18

Strength

10-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 022494

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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