0173-0915-13 |
0173-0915 |
HUMAN PRESCRIPTION DRUG |
ZEJULA |
niraparib |
TABLET, FILM COATED |
ORAL |
20230627 |
N/A |
NDA |
NDA214876 |
GlaxoSmithKline LLC |
NIRAPARIB TOSYLATE MONOHYDRATE |
300 mg/1 |
30 TABLET, FILM COATED in 1 BOTTLE (0173-0915-13) |
0173-0915-61 |
0173-0915 |
HUMAN PRESCRIPTION DRUG |
ZEJULA |
niraparib |
TABLET, FILM COATED |
ORAL |
20230627 |
N/A |
NDA |
NDA214876 |
GlaxoSmithKline LLC |
NIRAPARIB TOSYLATE MONOHYDRATE |
300 mg/1 |
30 TABLET, FILM COATED in 1 BOTTLE (0173-0915-61) |
0173-0912-61 |
0173-0912 |
HUMAN PRESCRIPTION DRUG |
ZEJULA |
niraparib |
TABLET, FILM COATED |
ORAL |
20230627 |
N/A |
NDA |
NDA214876 |
GlaxoSmithKline LLC |
NIRAPARIB TOSYLATE MONOHYDRATE |
200 mg/1 |
30 TABLET, FILM COATED in 1 BOTTLE (0173-0912-61) |
0173-0912-13 |
0173-0912 |
HUMAN PRESCRIPTION DRUG |
ZEJULA |
niraparib |
TABLET, FILM COATED |
ORAL |
20230627 |
N/A |
NDA |
NDA214876 |
GlaxoSmithKline LLC |
NIRAPARIB TOSYLATE MONOHYDRATE |
200 mg/1 |
30 TABLET, FILM COATED in 1 BOTTLE (0173-0912-13) |
0173-0909-13 |
0173-0909 |
HUMAN PRESCRIPTION DRUG |
ZEJULA |
niraparib |
TABLET, FILM COATED |
ORAL |
20230627 |
N/A |
NDA |
NDA214876 |
GlaxoSmithKline LLC |
NIRAPARIB TOSYLATE MONOHYDRATE |
100 mg/1 |
30 TABLET, FILM COATED in 1 BOTTLE (0173-0909-13) |