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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. ʲôÊÇFDAµÄTentative Approval? |
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5Â¥2008-12-04 09:11:13
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2Â¥2008-12-03 15:31:43
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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 |

3Â¥2008-12-03 21:52:08
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- ×¢²á: 2008-01-14
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4Â¥2008-12-04 08:34:01














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