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Hi,  As per "ANDA Submissions –Refuse to Receive for Lack of Justification of Impurity Limits- August 2016" Guidance :  FDA will RTR an ANDA under §314.101(d)(3) if the ANDA lacks supporting data or information to justify the proposed limits for specified identified and/or specified unidentified ...

As the product is within the shelf life , it must meet all the predefined product specifications. The near expiry test sample (DP) should not behave differently than the fresh test sample. Yes, some parameters might go change with age but definitely it should meet the shelf life specifications of the ...

Hi  The approved ANDA as well as the RLD is having debossing on the tablet.  Now we would like to go for imprinting on the tablet (with the same identification mark)  instead of debossing.  Is it acceptable to proceed for this change, any guidance / experience, please .. Regards, -------- ...

Hi,  One approved ANDA has 04 strengths ( tablet). Now need to change the approved formulation that falls under SUPAC Label II.  Also need to change the source of container closure system (MOC is same) along with no of count / Bt.  Taking 01 Exhibit batch of each strengths (for 04 strengths 04 EB ...

Hi,  Thank you for sharing your understanding.  Requirement for L2 changes ( SUPAC – IR ) for PAS : Multi-point dissolution profiles should be performed in water, 0.1 N HCl, and USP buffer media at pH 4.5, 6.5, and 7.5 for the proposed and currently accepted formulation. Based on that  below is ...