Elite Pharmaceuticals Inc (ELTP)

[ARbigguy1]

March 14 or 15, 2016=FDA acceptance (could be SOONER!) 20 days and counting down!
March 28 or 29, 2016 = "74-day Letter" (could be sooner)
The above dates were adjusted as mrwrn pointed out that Elite filed the NDA on 14 January 2016. mrwrn is correct! Check the Elite 8K dated 29 January 2016.
July 15, 2016 = PDUFA date for ELI 200 - the date specified in the 74-day letter letting us know the FDA's goal date for review/approval.

Just estimates but you get the picture! Keep in mind, it could all happen sooner than these estimates.

You will know within 60 days of submitting your NDA whether it has been accepted for filing (or conversely, if FDA refuses to file your application). If your application is accepted for filing (60 days after submission), then you will receive a 74-day letter, which confirms your action date, confirms standard versus priority review, and identifies any preliminary deficiencies in your application.