← FDA Drug Approvals (Drugs@FDA)

XYOSTED (AUTOINJECTOR)

NDA · New Drug Application · Sponsor: ANTARES PHARMA INC · Approved 2018-09-28

Drug application

FDA Application #

NDA209863

Application type

New Drug Application

Brand name

XYOSTED (AUTOINJECTOR)

Generic name

TESTOSTERONE ENANTHATE

Active ingredients

TESTOSTERONE ENANTHATE

Dosage form

SOLUTION

Route

SUBCUTANEOUS

Marketing status

Prescription

Sponsor

ANTARES PHARMA INC

Manufacturer

Antares Pharma, Inc.

First approval

2018-09-28

Source

Authoritative

Drugs@FDA application overview

Machine

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