Source facts
FDA issued a tentative approval letter for AFATINIB on 2026-03-19. The source metadata identifies ANDA 210804 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordTA · Tentative Approval Letter
AFATINIB — FDA Tentative Approval Letter (ANDA 210804)
Issued to MSN PHARMACEUTICALS INC. Application meets requirements but marketing is blocked (patent/exclusivity).
Issued
March 19, 2026Application
ANDA 505j • 210804
Product
AFATINIB
Company
MSN PHARMACEUTICALS INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for AFATINIB?
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: tentative approval.
- 2Application: ANDA 210804.
- 3Submission: original application.
- 4Sponsor: MSN PHARMACEUTICALS INC.
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 tentative approval letter (PDF)
Loading document viewer…
Common questions about the AFATINIB tentative approval letter
Is AFATINIB FDA approved?
Not for marketing yet. FDA granted tentative approval to ANDA 210804 for AFATINIB on March 19, 2026, meaning the application meets approval standards but patent or exclusivity protections block final approval. The product cannot be marketed until those conditions resolve and FDA issues final approval.
What is ANDA 210804?
ANDA 210804 is the application under which FDA issued this tentative approval letter for AFATINIB to MSN PHARMACEUTICALS INC. The letter is dated March 19, 2026.
What happens after an FDA tentative approval letter?
The product cannot be marketed yet. Tentative approval means the application meets FDA approval standards, but patent or exclusivity protections block final approval. The sponsor typically requests final approval as the blocking date approaches, and FDA re-verifies that the approval conditions still hold before granting it.