Drugs

NIH Funded Pediatric Labeling Changes

 

Product Name         FDA Requested Label ChangesFinal Federal Register Notice
including Summary Review
Sodium Nitroprusside   ANDA 71961 labeling changes accepted
by sponsor - Dec. 2013 (PDF - 53KB)
FR Vol 79 No. 16 pg 4167 
Friday, January 24, 2014
Product Name         FDA Requested Label ChangesFinal Federal Register Notice
including Summary Review
Meropenem for Injection  Merrem IV labeling changes accepted
by sponsor - Feb. 20, 2015 (PDF - 91KB)
FR Vol 80 No. 102 pg 30467 
Thursday, May 28, 2015

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