Source facts
FDA issued an approval letter for CLONAZEPAM on 2026-05-26. The source metadata identifies ANDA 216988 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
CLONAZEPAM — FDA Approval Letter (ANDA 216988)
Issued to RUBICON RESEARCH. Application is approved as submitted.
Issued
May 26, 2026Application
ANDA 505j • 216988
Product
CLONAZEPAM
Company
RUBICON RESEARCH
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for CLONAZEPAM?
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 216988.
- 3Submission: original application.
- 4Sponsor: RUBICON RESEARCH.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the CLONAZEPAM approval letter
Is CLONAZEPAM FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 216988 for CLONAZEPAM, sponsored by RUBICON RESEARCH, on May 26, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 216988?
ANDA 216988 is the application under which FDA issued this approval letter for CLONAZEPAM to RUBICON RESEARCH. The letter is dated May 26, 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.