New Suitability Petitions - April 2025

Please find attached the report on list of drugs with Suitability Petitions activities for the month of April 2025 (filed / accepted / rejected / approved). The current month report covers the below products:

1. Linezolid
2. Potassium Acetate
3. Testosterone Enanthate
4. Hydrocortisone
5. Quetiapine Fumarate
6. Ceftriaxone
7. Spironolactone
8. Indomethacin
9. Ketorolac Tromethamine
10. Cyclobenzaprine Hydrochloride
11. Benazepril Hydrochloride
12. Piroxicam
13. Amlodipine Besylate, Hydrochlorothiazide, Valsartan
14. Benazepril Hydrochloride and Hydrochlorothiazide
15. Benazepril Hydrochloride
16. Lumateperone Tosylate
17. Hydrochlorothiazide
18. Dicyclomine Hydrochloride

About Suitability Petitions: A suitability petition is a request by an ANDA sponsor (called the “petitioner”) to submit an ANDA for a proposed generic drug that differs from the reference listed drug (RLD). Certain differences between a reference listed drug (RLD) and a proposed generic drug product may be permitted in an ANDA if these differences are the subject of an approved suitability petition submitted under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act.