Source facts
FDA issued an approval letter for FOSAMAX PLUS D on 2026-02-05. The source metadata identifies NDA 021762 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
FOSAMAX PLUS D — FDA Approval Letter (NDA 021762)
Issued to ORGANON LLC. Application is approved as submitted.
Issued
February 5, 2026Application
NDA 505b1 • 021762
Product
FOSAMAX PLUS D
Company
ORGANON LLC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for FOSAMAX PLUS D?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 021762.
- 3Submission: supplement.
- 4Sponsor: ORGANON LLC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
Read the full FDA approval letter (PDF)
Loading document viewer…
Common questions about the FOSAMAX PLUS D approval letter
Is FOSAMAX PLUS D FDA approved?
This letter documents an FDA approval action: FDA approved NDA 021762 for FOSAMAX PLUS D, sponsored by ORGANON LLC, on February 5, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 021762?
NDA 021762 is the application under which FDA issued this approval letter for FOSAMAX PLUS D to ORGANON LLC. The letter is dated February 5, 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.