[RegAffairs]SPL for package insert in original ANDA

["kiran" <dra.gland@glandpharma.com>]

Dear  All,

In initial ANDA submission, which format is used for preparing SPL 
for package insert. is it in SPL R3 format or in SPL R4 format. 
Please suggest.

Thanks,
Kiran

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kiran
dra.gland@glandpharma.com


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