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Dear all,
i have one query that what isthe difference between
505b(2) and suitability petition, since definition wise both are seems
to be equivalent for filling.
(Both are sameness as different dosage form, dose and label claim).
In case of suitability petition is there require any additional
studies like
clinical studies.
Is there any literature for this difference, please provide me soon.
Waiting in anticipation,
With regards,
alkesh
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