Source facts
FDA issued an approval letter for ZOLPIDEM TARTRATE on 2026-07-21. The source metadata identifies ANDA 220717 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ZOLPIDEM TARTRATE — FDA Approval Letter (ANDA 220717)
Issued to UMEDICA LABS PVT. Application is approved as submitted.
Issued
July 21, 2026Application
ANDA 505j • 220717
Product
ZOLPIDEM TARTRATE
Company
UMEDICA LABS PVT
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ZOLPIDEM TARTRATE?
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Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 220717.
- 3Submission: original application.
- 4Sponsor: UMEDICA LABS PVT.
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Common questions about the ZOLPIDEM TARTRATE approval letter
Is ZOLPIDEM TARTRATE FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 220717 for ZOLPIDEM TARTRATE, sponsored by UMEDICA LABS PVT, on July 21, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 220717?
ANDA 220717 is the application under which FDA issued this approval letter for ZOLPIDEM TARTRATE to UMEDICA LABS PVT. The letter is dated July 21, 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.