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北京石油化工学院2026年研究生招生接收调剂公告
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ienjoysun

银虫 (著名写手)

[交流] 什么是FDA的Tentative Approval?

Click on a column header to re-sort the table:
  
ActionDate   Supplement Number  Approval Type  Letters, Reviews, Labels,
Patient Package Insert   Note
02/06/2008  000  Approval Letter    Label is not available
on this site.  
12/27/2002  000  Tentative Approval     Label is not available
on this site.  
什么是FDA的Tentative Approval?
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ienjoysun

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thanks a lot!!
But, some product which is not generic  drug have tentative approval. why?
4楼2008-12-04 08:34:01
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ienjoysun

银虫 (著名写手)

Action Date   Supplement Number  Approval Type  Letters, Reviews, Labels,?Patient Package Insert   Note
02/06/2008  000  Approval Letter    Label is not available on this site.  
12/27/2002  000  Tentative Approval     Label is not available on this site.
2楼2008-12-03 15:31:43
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llb1978

金虫 (正式写手)


clkk216(金币+1,VIP+0):多谢~! (*^__^*) ……
http://www.fda.gov/cder/drugsatfda/glossary.htm#T

Tentative Approval
If a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference listed drug product, FDA issues a tentative approval letter to the applicant. The tentative approval letter details the circumstances associated with the tentative approval. FDA delays final approval of the generic drug product until all patent or exclusivity issues have been resolved. A tentative approval does not allow the applicant to market the generic drug product
严于律己,宽以待人
3楼2008-12-03 21:52:08
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xiaolingwei2007

Becau these new drug have other defects to be suspended.
5楼2008-12-04 09:11:13
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