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Sunday, December 22, 2019
Approval time for CGT designated ANDAs: Review
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Till date, USFDA has approved 18 ANDAs with CGT exclusivity. We have reviewed approval details of 17 out of these 18 ANDAs....
Sunday, December 8, 2019
NCE-1 filing: scenario year-to-date
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Year-to-date, the FDA has reported paragraph IV ANDA submissions against 11 brand products having NCE-1 dates in 2019. Most of ...
Sunday, October 20, 2019
505(b)(2) and Generic Updates
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NEWS FROM USA NEW EXCLUSIVITY LISTINGS IN THE ORANGE BOOK New PC (Patent Challenge) exclusivity listing in the orange b...
Sunday, September 29, 2019
Weekly summary September 23 - 27, 2019
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NEWS FROM USA NEW GENERICS LAUNCHES IN US Launch date DRUG Marketer Corresponding R...
Sunday, September 22, 2019
Weekly summary: 16 Sep. - 20 Sep.2019
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NEWS FROM USA 505(b)(2) APPROVALS Approval Date Product Name NDA Sponsor Comment ...
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