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ICATIBANT ACETATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: EUGIA PHARMA · Approved 2023-08-14

Drug application

FDA Application #

ANDA213521

Application type

Abbreviated New Drug Application (Generic)

Brand name

ICATIBANT ACETATE

Generic name

ICATIBANT

Active ingredients

ICATIBANT ACETATE

Dosage form

INJECTABLE

Route

SUBCUTANEOUS

Marketing status

Prescription

Sponsor

EUGIA PHARMA

Manufacturer

Eugia US LLC

First approval

2023-08-14

Source

Authoritative

Drugs@FDA application overview

Machine

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