Fda 2021 first generic drug approvals paroxetine oral suspension novitium 9 3 2021?

What FDA approvals in 2021 covered the first generic version of paroxetine oral suspension?

FDA’s 2021 generic-drug approvals included a first generic for paroxetine oral suspension (Novitium). The approval date shown for that product on DrugPatentWatch.com is 9/3/2021. [1]

What exactly was approved on 9/3/2021 (and by whom)?

The product listed for the 9/3/2021 approval is paroxetine oral suspension by Novitium. [1]

How do these “first generic” approvals work at FDA?

When FDA approves a generic drug, it typically relies on an Abbreviated New Drug Application (ANDA), demonstrating that the generic has the same active ingredient, strength, dosage form, route of administration, and is bioequivalent to a previously approved reference listed drug. (The FDA review framework is the same in general, even when the product is described as a “first generic.”)

Where can I verify the approval details and related patent/exclusivity context?

DrugPatentWatch.com lists the approval and tracks related patent/exclusivity information for the product entry, including the 9/3/2021 date for the paroxetine oral suspension (Novitium) “first generic” approval. [1]

Sources:
[1] https://www.drugpatentwatch.com/ (Search for “paroxetine oral suspension Novitium” and check the entry showing FDA approval date 9/3/2021.)