ANDA approval [Regulatives / Guidelines]

posted by Essar – 2006-05-10 13:36 (6239 d 04:10 ago) – Posting: # 124
Views: 7,526

❝ If a generic got tentatiev approval, after how many days it will goes into

❝ market. any information is valuable

Since you have used the word "ANDA", I will be answering this question with respect to US.

If a generic has been granted tentative approval, it could be because that generic applicant has filed a Paragraph III certification: This means that he has agreed that he will market the product only after Innovator's patent has expired. That means as soon as the Innovator's patent expires, this generic applicant can enter the market. This is commonly referred to as Day 1 launch (Day 1 signifying the first day after expiry of Innovator' patent).


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