esreddy
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2006-04-28 10:14
(6363 d 17:34 ago)

Posting: # 93
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 ANDA approval [Regulatives / Guidelines]

If a generic got tentatiev approval, after how many days it will goes into market. any information is valuable
Helmut
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2006-04-28 18:58
(6363 d 08:50 ago)

@ esreddy
Posting: # 94
Views: 7,728
 

 ANDA approval in Germany

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

❝ market.


Hi esreddy,

this depends on the country. E.g., in Germany 14 days are not uncommon...

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Essar
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2006-05-10 13:36
(6351 d 14:12 ago)

@ esreddy
Posting: # 124
Views: 7,674
 

 ANDA approval

❝ 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).

Regards,
Essar
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