Source facts
FDA issued an approval letter for SYNALGOS-DC on 2026-06-23. The source metadata identifies NDA 011483 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
SYNALGOS-DC — FDA Approval Letter (NDA 011483)
Issued to SUN PHARM INDUSTRIES. Application is approved as submitted.
Issued
June 23, 2026Application
NDA 505b1 • 011483
Product
SYNALGOS-DC
Company
SUN PHARM INDUSTRIES
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for SYNALGOS-DC?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 011483.
- 3Submission: supplement.
- 4Sponsor: SUN PHARM INDUSTRIES.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the SYNALGOS-DC approval letter
Is SYNALGOS-DC FDA approved?
This letter documents an FDA approval action: FDA approved NDA 011483 for SYNALGOS-DC, sponsored by SUN PHARM INDUSTRIES, on June 23, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 011483?
NDA 011483 is the application under which FDA issued this approval letter for SYNALGOS-DC to SUN PHARM INDUSTRIES. The letter is dated June 23, 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.