Orange Book product · Brand (NDA)

OMNICEF

CEFDINIR

Brand (NDA)NDA 050749DISCN ABBVIE

View CEFDINIR family Open on FDA Orange Book

At a glance

Dec 04, 1997

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Dec 04, 1997
28 yr 11 mo ago
Today

Pharmaceutical detail

Active ingredient

CEFDINIR

Strength

125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 050749

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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