)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
talc (UNII: 7SEV7J4R1U)
Ferric Oxide Yellow (UNII: EX438O2MRT)
PRODUCT CHARACTERISTICS
Color yellow (YELLOW) Score no score
Shape OVAL (OVAL) Size 16mm
Flavor Imprint Code C3
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:69660-203-91 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2016
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209115 12/19/2016
RUBRACA
rucaparib tablet, film coated
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69660-202
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
rucaparib camsylate (UNII: 41AX9SJ8KO) (rucaparib - UNII:8237F3U7EH) rucaparib 250 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
cellulose, microcrystalline (UNII: OP1R32D61U)
sodium starch glycolate type a potato (UNII: 5856J3G2A2)
silicon dioxide (UNII: ETJ7Z6XBU4)
magnesium stearate (UNII: 70097M6I30)
polyvinyl alcohol, unspecified (UNII: 532B59J990)
titanium dioxide (UNII: 15FIX9V2JP)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
talc (UNII: 7SEV7J4R1U)
PRODUCT CHARACTERISTICS
Color white (WHITE) Score no score
Shape DIAMOND (DIAMOND) Size 15mm
Flavor Imprint Code C25
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:69660-202-91 60 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2017
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209115 05/01/2017
LABELER - CLOVIS ONCOLOGY, INC. (830871518) |
