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LEUPROLIDE ACETATE FOR DEPOT SUSPENSION

NDA · New Drug Application · Sponsor: INVAGEN PHARMS · Approved 2018-08-28

Drug application

FDA Application #

NDA205054

Application type

New Drug Application

Brand name

LEUPROLIDE ACETATE FOR DEPOT SUSPENSION

Generic name

LEUPROLIDE ACETATE

Active ingredients

LEUPROLIDE ACETATE

Dosage form

FOR SUSPENSION

Route

INTRAMUSCULAR

Marketing status

Prescription

Sponsor

INVAGEN PHARMS

Manufacturer

Avyxa Pharma, LLC

First approval

2018-08-28

Source

Authoritative

Drugs@FDA application overview

Machine

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