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Astagraf XL Approval History

FDA Approved: Yes (First approved July 19, 2013)
Brand name: Astagraf XL
Generic name: tacrolimus
Dosage form: Extended-Release Capsules
Company: Astellas Pharma US, Inc.
Treatment for: Organ Transplant, Rejection Prophylaxis

Astagraf XL (tacrolimus) is a calcineurin-inhibitor immunosuppressant for the prophylaxis of organ rejection in patients receiving a kidney transplant.

Development History and FDA Approval Process for Astagraf XL

DateArticle
Jul 22, 2013Approval Astellas Announces FDA Approval of Astagraf XL (tacrolimus extended-release capsules) for the Prophylaxis of Organ Rejection
Dec 26, 2005NDA for Immunosuppressant FK506 Modified Release Formulation Submitted in the US

Further information

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