Source facts
FDA issued an approval letter for DIAZEPAM on 2026-01-13. The source metadata identifies ANDA 217468 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
DIAZEPAM — FDA Approval Letter (ANDA 217468)
Issued to NAVINTA LLC. Application is approved as submitted.
Issued
January 13, 2026Application
ANDA 505j • 217468
Product
DIAZEPAM
Company
NAVINTA LLC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for DIAZEPAM?
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: ANDA 217468.
- 3Submission: original application.
- 4Sponsor: NAVINTA LLC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the DIAZEPAM approval letter
Is DIAZEPAM FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 217468 for DIAZEPAM, sponsored by NAVINTA LLC, on January 13, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 217468?
ANDA 217468 is the application under which FDA issued this approval letter for DIAZEPAM to NAVINTA LLC. The letter is dated January 13, 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.