Elite Pharmaceuticals Inc (ELTP): so why file an entirely new application...

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Elite Pharmaceuticals Inc (ELTP)

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Re: WeeZuhl post# 388327

Monday, 09/25/2023 9:15:16 PM

Monday, September 25, 2023 9:15:16 PM

so why file an entirely new application in August 2023?

https://www.fda.gov/industry/generic-drug-user-fee-amendments/frequently-asked-questions-how-gdufa-affects-abbreviated-new-drug-application-anda-submissions#Q2

Q2. What happens if FDA identifies deficiencies in an ANDA?
...
The sponsor may decide to submit additional materials to correct the deficiencies, but the resulting amended ANDA will be considered a new ANDA submission, received as of the new date, requiring a new GDUFA fee.
...

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