This report identifies new Suitability Petitions filed, rejected and/or approved by the USFDA. The report includes the reason for Suitability Petition along with the USFDA document published on that Suitability Petition. 

Please find attached the report on list of drugs with Suitability Petitions activities for the month of September 2024 (filed / accepted / rejected / approved). The current month report covers the below products:

1. Bisoprolol Fumarate
2. Clonidine Hydrochloride
3. Ascorbic Acid
4. Fludrocortione Acetate
5. Dexamethasone
6. Cyclobenzaprine Hydrochloride

Please find attached the report on list of drugs with Suitability Petitions activities for the month of October 2024 (filed / accepted / rejected / approved). The current month report covers the below products:

Please find attached the report on list of drugs with Suitability Petitions activities for the month of September 2024 (filed / accepted / rejected / approved). The current month report covers the below products:

1.                  Cyproheptadine Hydrochloride

2.                  Amlodipine; Hydrochlorothiazide; Valsartan

3.                  Omeprazole and Sodium Bicarbonate

4.                  Triamcinolone Acetonide

5.                  Cisatracurium Besylate

6.                  Midodrine Hydrochloride

7.                  Dapsone

8.                  Lidocaine

9.                  Levothyroxine Sodium

10.             Bupivacaine Hydrochloride

11.             Levetiracetam In Sodium Chloride

12.             Vasopressin

13.             Metronidazole

14.             Hydromorphone Hydrochloride

This is a report on list of drugs with Suitability Petitions activities for the month of December 2024 (filed / accepted / rejected / approved). 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).