Reference trademark issue [Regulatives / Guidelines]

posted by rajasekharkakarla – India, 2018-07-24 09:05 (798 d 10:15 ago) – Posting: # 19087
Views: 1,914

Dear All,

I prepared protocol for Mesalamine delayed-release tablets 1.2 gm for USFDA submission, i written reference name as Lialda™ (mesalamine) delayed release tablets 1.2 gm with trademark TM and the protocol was approved by EC. But as per COA it is mentioned as Lialda®, there is change in trademark. kindly suggest whether i need to go with ammendment/not.

Regards'
Kakarla

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