Source facts
FDA issued a tentative approval letter for VILOXAZINE HYDROCHLORIDE on 2026-06-08. The source metadata identifies ANDA 220326 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordTA · Tentative Approval Letter
VILOXAZINE HYDROCHLORIDE — FDA Tentative Approval Letter (ANDA 220326)
Issued to APPCO PHARMA LLC. Application meets requirements but marketing is blocked (patent/exclusivity).
Issued
June 8, 2026Application
ANDA 505j • 220326
Product
VILOXAZINE HYDROCHLORIDE
Company
APPCO PHARMA LLC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for VILOXAZINE HYDROCHLORIDE?
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 220326.
- 3Submission: original application.
- 4Sponsor: APPCO PHARMA LLC.
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 VILOXAZINE HYDROCHLORIDE tentative approval letter
Is VILOXAZINE HYDROCHLORIDE FDA approved?
Not for marketing yet. FDA granted tentative approval to ANDA 220326 for VILOXAZINE HYDROCHLORIDE on June 8, 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 220326?
ANDA 220326 is the application under which FDA issued this tentative approval letter for VILOXAZINE HYDROCHLORIDE to APPCO PHARMA LLC. The letter is dated June 8, 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.