← FDA Drug Approvals (Drugs@FDA)

CEFDINIR

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2021-02-19

Drug application

FDA Application #

ANDA210534

Application type

Abbreviated New Drug Application (Generic)

Brand name

CEFDINIR

Generic name

CEFDINIR

Active ingredients

CEFDINIR

Dosage form

FOR SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

ALKEM LABS LTD

Manufacturer

Ascend Laboratories, LLC

First approval

2021-02-19

Source

Authoritative

Drugs@FDA application overview

Machine

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