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Registerstrange question: An RLD (RS) which can be scored [Regulatives / Guidelines]
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
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
Complete thread:
- strange question: An RLD (RS) which can be scoredjag009 2022-09-08 19:30 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- strange question: An RLD (RS) which can be scored dshah 2022-09-09 17:52
- strange question: An RLD (RS) which can be scored wienui 2022-09-14 17:25
Ing. Helmut Schütz