Source facts
FDA issued an approval letter for DOXIL (LIPOSOMAL) on 2026-03-12. The source metadata identifies NDA 050718 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
DOXIL (LIPOSOMAL) — FDA Approval Letter (NDA 050718)
Issued to BAXTER HLTHCARE CORP. Application is approved as submitted.
Issued
March 12, 2026Application
NDA 505b1 • 050718
Product
DOXIL (LIPOSOMAL)
Company
BAXTER HLTHCARE CORP
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for DOXIL (LIPOSOMAL)?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 050718.
- 3Submission: supplement.
- 4Sponsor: BAXTER HLTHCARE CORP.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the DOXIL (LIPOSOMAL) approval letter
Is DOXIL (LIPOSOMAL) FDA approved?
This letter documents an FDA approval action: FDA approved NDA 050718 for DOXIL (LIPOSOMAL), sponsored by BAXTER HLTHCARE CORP, on March 12, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 050718?
NDA 050718 is the application under which FDA issued this approval letter for DOXIL (LIPOSOMAL) to BAXTER HLTHCARE CORP. The letter is dated March 12, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.