ARISTADA (ARIPIPRAZOLE LAUROXIL)
Summary
FDA approved ARISTADA (ARIPIPRAZOLE LAUROXIL) by ALKERMES INC. NDA (New Drug) approval (Labeling) on 2025-01-22. SUSPENSION, EXTENDED RELEASE, INTRAMUSCULAR.
Details
Source
Drug Approval
External ID
NDA207533-31
Action Date
2025-01-22
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
ARISTADA (generic: ARIPIPRAZOLE LAUROXIL), SUSPENSION, EXTENDED RELEASE, INTRAMUSCULAR. Application: NDA207533
Company
Context & Analysis
Frequently Asked Questions
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This is the only FDA action we have on record for ALKERMES INC in our database.
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The official record is available on FDA.gov. Search for "NDA207533-31" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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