Source facts
FDA issued an approval letter for ZAYNICH on 2026-06-02. The source metadata identifies NDA 220787 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ZAYNICH — FDA Approval Letter (NDA 220787)
Issued to WOCKHARDT BIO AG. Application is approved as submitted.
Issued
June 2, 2026Application
NDA 505b1 • 220787
Product
ZAYNICH
Company
WOCKHARDT BIO AG
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ZAYNICH?
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 220787.
- 3Submission: original application.
- 4Sponsor: WOCKHARDT BIO AG.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
Read the full FDA approval letter (PDF)
Loading document viewer…
Common questions about the ZAYNICH approval letter
Is ZAYNICH FDA approved?
This letter documents an FDA approval action: FDA approved NDA 220787 for ZAYNICH, sponsored by WOCKHARDT BIO AG, on June 2, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 220787?
NDA 220787 is the application under which FDA issued this approval letter for ZAYNICH to WOCKHARDT BIO AG. The letter is dated June 2, 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.