ASTAGRAF XL (TACROLIMUS EXTENDED-RELEASE CAPSULES)
Summary
FDA approved ASTAGRAF XL (TACROLIMUS EXTENDED-RELEASE CAPSULES) by ASTELLAS. NDA (New Drug) approval (Labeling) on 2023-09-14. CAPSULE, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
NDA204096-11
Action Date
2023-09-14
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
ASTAGRAF XL (generic: TACROLIMUS EXTENDED-RELEASE CAPSULES), CAPSULE, EXTENDED RELEASE, ORAL. Application: NDA204096
Company
Context & Analysis
ASTELLAS has 6 FDA actions in our database.
Frequently Asked Questions
How often does ASTELLAS have FDA actions?
ASTELLAS has 6 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA204096-11" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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