Registrants (1)
Sumitomo Pharma Switzerland GmbH
480146015
Products (1)
Orgovyx
72974-120
NDA214621
NDA (C73594)
ORAL
January 18, 2024
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4DClass: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7FClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
RelugolixActive
Code: P76B05O5V6Class: ACTIBQuantity: 120 mg in 1 1