Source facts
FDA issued an approval letter for ZIAC on 2026-07-28. The source metadata identifies NDA 020186 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ZIAC — FDA Approval Letter (NDA 020186)
Issued to TEVA BRANDED PHARM. Application is approved as submitted.
Issued
July 28, 2026Application
NDA 505b1 • 020186
Product
ZIAC
Company
TEVA BRANDED PHARM
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ZIAC?
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 020186.
- 3Submission: supplement.
- 4Sponsor: TEVA BRANDED PHARM.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ZIAC approval letter
Is ZIAC FDA approved?
This letter documents an FDA approval action: FDA approved NDA 020186 for ZIAC, sponsored by TEVA BRANDED PHARM, on July 28, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 020186?
NDA 020186 is the application under which FDA issued this approval letter for ZIAC to TEVA BRANDED PHARM. The letter is dated July 28, 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.