68135-301-22 |
68135-301 |
HUMAN PRESCRIPTION DRUG |
Kuvan |
SAPROPTERIN DIHYDROCHLORIDE |
POWDER, FOR SOLUTION |
ORAL |
20140221 |
N/A |
NDA |
NDA205065 |
BioMarin Pharmaceutical Inc. |
SAPROPTERIN DIHYDROCHLORIDE |
100 mg/1 |
30 PACKET in 1 CARTON (68135-301-22) / 1 POWDER, FOR SOLUTION in 1 PACKET (68135-301-11) |
68135-482-11 |
68135-482 |
HUMAN PRESCRIPTION DRUG |
Kuvan |
sapropterin dihydrochloride |
POWDER, FOR SOLUTION |
ORAL |
20150527 |
N/A |
NDA |
NDA205065 |
BioMarin Pharmaceutical Inc. |
SAPROPTERIN DIHYDROCHLORIDE |
500 mg/1 |
30 PACKET in 1 CARTON (68135-482-11) / 1 POWDER, FOR SOLUTION in 1 PACKET (68135-482-10) |