Anand
☆    

India,
2015-03-11 12:32
(4125 d 02:37 ago)

Posting: # 14558
Views: 2,475
 

 Score Line [Regulatives / Guidelines]

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Dear All,

Request to clarify the below comment,

Background:

We Developed Generic Product without Score line but RLD having Score Line.

We Developed without score line based on PIL suggested that divided dose not mentioned for below 12 years.

Query: Whether USFDA will allow our ANDA or not?

Thanks in Advance.

Regards,
A.Anand
Bio-PK
 
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