TRESIBA (INSULIN DEGLUDEC)
Summary
FDA approved TRESIBA (INSULIN DEGLUDEC) by NOVO. BLA (Biologic) approval (Labeling) on 2022-07-01. SOLUTION, SUBCUTANEOUS.
Details
Source
Drug Approval
External ID
BLA203314-18
Action Date
2022-07-01
Status
Approved
Category
drug
Product Code
BLA (Biologic)
Product Description
TRESIBA (generic: INSULIN DEGLUDEC), SOLUTION, SUBCUTANEOUS. Application: BLA203314
Company
Context & Analysis
NOVO has 6 FDA actions in our database.
Frequently Asked Questions
How often does NOVO have FDA actions?
NOVO 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 "BLA203314-18" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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