Source facts
FDA issued an approval letter for ABSORICA LD on 2026-06-16. The source metadata identifies NDA 211913 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ABSORICA LD — FDA Approval Letter (NDA 211913)
Issued to SUN PHARM. Application is approved as submitted.
Issued
June 16, 2026Application
NDA 505b1 • 211913
Product
ABSORICA LD
Company
SUN PHARM
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ABSORICA LD?
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: NDA 211913.
- 3Submission: supplement.
- 4Sponsor: SUN PHARM.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ABSORICA LD approval letter
Is ABSORICA LD FDA approved?
This letter documents an FDA approval action: FDA approved NDA 211913 for ABSORICA LD, sponsored by SUN PHARM, on June 16, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 211913?
NDA 211913 is the application under which FDA issued this approval letter for ABSORICA LD to SUN PHARM. The letter is dated June 16, 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.