strange question: An RLD (RS) which can be scored [Regulatives / Guidelines]

posted by jag009  – NJ, 2022-09-08 21:30 (86 d 16:01 ago) – Posting: # 23279
Views: 686

Hi all,

A strange question... for FDA (Or anywhere else), if a RS or RLD product is scorable (100 mg, scored into 2 50 mg), can one file an ANDA for a 50 mg generic by comparing 2x50 mg vs the scorable 100 mg reference? My initial guess is no but strange things do happen...

Any thought?

thx
john

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