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BBDid you notice Teva has 500mg cap approved

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iwishiknew   Friday, 09/11/20 04:32:47 PM
Re: Biobillionair post# 298291
Post # of 348694 
BB
Did you notice Teva has 500mg cap approved - but not H or R ?

Also- Teva approval letter dated 6/5/2020 states...
The introduction or delivery for introduction into interstate
commerce of this drug product before the final approval date is prohibited... until the Agency issues the final approval letter, this drug product will not be deemed approved for marketing under section 505(j) of the FD&CAct, and will not be listed in the Orange Book. Should you believe that there are grounds for issuing the final approval letter prior to December 13, 2022, you should amend your ANDA accordingly.

With respect to both strengths, the Agency notes that the '0,086, '994, '077, '245, '144, '871, '185, '475,
'041, '892, '826, '272, '001, '984, '985, '986, '537, '954, '517, '287, '935, '936, '937, '840, '924, '925, '861,
and '054 patents were submitted to the Agency after submission of your ANDA. In addition, with
respect to the 1 gram strength, the Agency notes that the '472 and '166 patents were submitted to the Agency after submission of your ANDA. Litigation, if any, with respect to these patents would not create a statutory stay of approval.

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