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ASTAGRAF XL

NDA · New Drug Application · Sponsor: ASTELLAS · Approved 2013-07-19

Drug application

FDA Application #

NDA204096

Application type

New Drug Application

Brand name

ASTAGRAF XL

Generic name

TACROLIMUS EXTENDED-RELEASE CAPSULES

Active ingredients

TACROLIMUS

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

ASTELLAS

Manufacturer

Astellas Pharma US, Inc.

First approval

2013-07-19

Source

Authoritative

Drugs@FDA application overview

Machine

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