Bioequivalence and Bioavailability Forum • BE using non RLD

BE using non RLD [Regulatives / Guidelines]

posted by jag009 – NJ, 2013-08-04 22:20 (4706 d 12:54 ago) – Posting: # 11194
Views: 6,357

Hi,

❝ I do see on approved ANDA list, some companies only have 75 mg strength. Does it make any sense?

I don't understand your question. You mean 75mg exists as an RLD and the 300mg also exists as an RLD?

Like i said, if you want to use 75mg as RLD and it currently does not exist as RLD on the orange book, write a petition with reasons and send to FDA.

John

Complete thread:

BE using non RLD zheng791 2013-08-03 21:45
- BE using non RLD ElMaestro 2013-08-03 22:17
  - BE using non RLD jag009 2013-08-03 22:51
    - BE using non RLD zheng791 2013-08-03 23:55
      - BE using non RLDjag009 2013-08-04 20:20
        
        BE using non RLD luvblooms 2013-08-05 05:57
        
        BE using non RLD ElMaestro 2013-08-05 10:44
        
        BE using non RLD luvblooms 2013-08-05 13:46
        
        BE using non RLD ElMaestro 2013-08-05 13:59
        
        BE using non RLD luvblooms 2013-08-05 14:31
        
        BE using non RLD ElMaestro 2013-08-05 15:04
        Very strange! jag009 2013-08-05 16:02
        
        Very strange! Helmut 2013-08-05 16:37
        
        Very strange! jag009 2013-08-05 16:45
        
        Very strange! luvblooms 2013-08-05 17:30
        
        Very strange! jag009 2013-08-05 17:52