Source facts
FDA issued a tentative approval letter for AMPHETAMINE on 2026-02-11. The source metadata identifies ANDA 220284 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordTA · Tentative Approval Letter
AMPHETAMINE — FDA Tentative Approval Letter (ANDA 220284)
Issued to GRANULES PHARMACEUTICALS INC. Application meets requirements but marketing is blocked (patent/exclusivity).
Issued
February 11, 2026Application
ANDA 505j • 220284
Product
AMPHETAMINE
Company
GRANULES PHARMACEUTICALS INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for AMPHETAMINE?
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 220284.
- 3Submission: original application.
- 4Sponsor: GRANULES PHARMACEUTICALS INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the AMPHETAMINE tentative approval letter
Is AMPHETAMINE FDA approved?
Not for marketing yet. FDA granted tentative approval to ANDA 220284 for AMPHETAMINE on February 11, 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 220284?
ANDA 220284 is the application under which FDA issued this tentative approval letter for AMPHETAMINE to GRANULES PHARMACEUTICALS INC. The letter is dated February 11, 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.