Source facts
FDA issued an approval letter for CITALOPRAM HYDROBROMIDE on 2026-06-09. The source metadata identifies ANDA 219985 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
CITALOPRAM HYDROBROMIDE — FDA Approval Letter (ANDA 219985)
Issued to AUROBINDO PHARMA LTD. Application is approved as submitted.
Issued
June 9, 2026Application
ANDA 505j • 219985
Product
CITALOPRAM HYDROBROMIDE
Company
AUROBINDO PHARMA LTD
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for CITALOPRAM HYDROBROMIDE?
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Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 219985.
- 3Submission: original application.
- 4Sponsor: AUROBINDO PHARMA LTD.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the CITALOPRAM HYDROBROMIDE approval letter
Is CITALOPRAM HYDROBROMIDE FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 219985 for CITALOPRAM HYDROBROMIDE, sponsored by AUROBINDO PHARMA LTD, on June 9, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 219985?
ANDA 219985 is the application under which FDA issued this approval letter for CITALOPRAM HYDROBROMIDE to AUROBINDO PHARMA LTD. The letter is dated June 9, 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.