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OTREXUP

NDA · New Drug Application · Sponsor: ASSERTIO SPECLTY · Approved 2013-10-11

Drug application

FDA Application #

NDA204824

Application type

New Drug Application

Brand name

OTREXUP

Generic name

METHOTREXATE

Active ingredients

METHOTREXATE

Dosage form

SOLUTION

Route

SUBCUTANEOUS

Marketing status

Discontinued

Sponsor

ASSERTIO SPECLTY

Manufacturer

Antares Pharma, Inc.

First approval

2013-10-11

Source

Authoritative

Drugs@FDA application overview

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