| 80725-820-60 |
80725-820 |
HUMAN PRESCRIPTION DRUG |
DROXIA |
Hydroxyurea |
CAPSULE |
ORAL |
20250911 |
N/A |
NDA |
NDA016295 |
Waylis Therapeutics LLC |
HYDROXYUREA |
200 mg/1 |
60 CAPSULE in 1 BOTTLE (80725-820-60) |
| 61269-403-60 |
61269-403 |
HUMAN PRESCRIPTION DRUG |
DROXIA |
HYDROXYUREA |
CAPSULE |
ORAL |
20150716 |
N/A |
NDA |
NDA016295 |
H2-Pharma LLC |
HYDROXYUREA |
300 mg/1 |
60 CAPSULE in 1 BOTTLE (61269-403-60) |
| 80725-810-10 |
80725-810 |
HUMAN PRESCRIPTION DRUG |
HYDREA |
Hydroxyurea |
CAPSULE |
ORAL |
20250911 |
N/A |
NDA |
NDA016295 |
Waylis Therapeutics LLC |
HYDROXYUREA |
500 mg/1 |
100 CAPSULE in 1 BOTTLE, PLASTIC (80725-810-10) |
| 61269-835-10 |
61269-835 |
HUMAN PRESCRIPTION DRUG |
HYDREA |
HYDROXYUREA |
CAPSULE |
ORAL |
20090601 |
N/A |
NDA |
NDA016295 |
H2-Pharma LLC |
HYDROXYUREA |
500 mg/1 |
100 CAPSULE in 1 BOTTLE (61269-835-10) |
| 80725-840-60 |
80725-840 |
HUMAN PRESCRIPTION DRUG |
DROXIA |
Hydroxyurea |
CAPSULE |
ORAL |
20250911 |
N/A |
NDA |
NDA016295 |
Waylis Therapeutics LLC |
HYDROXYUREA |
400 mg/1 |
60 CAPSULE in 1 BOTTLE (80725-840-60) |
| 61269-402-60 |
61269-402 |
HUMAN PRESCRIPTION DRUG |
DROXIA |
HYDROXYUREA |
CAPSULE |
ORAL |
20150716 |
N/A |
NDA |
NDA016295 |
H2-Pharma LLC |
HYDROXYUREA |
200 mg/1 |
60 CAPSULE in 1 BOTTLE (61269-402-60) |
| 80725-830-60 |
80725-830 |
HUMAN PRESCRIPTION DRUG |
DROXIA |
Hydroxyurea |
CAPSULE |
ORAL |
20250911 |
N/A |
NDA |
NDA016295 |
Waylis Therapeutics LLC |
HYDROXYUREA |
300 mg/1 |
60 CAPSULE in 1 BOTTLE (80725-830-60) |
| 61269-404-60 |
61269-404 |
HUMAN PRESCRIPTION DRUG |
DROXIA |
HYDROXYUREA |
CAPSULE |
ORAL |
20150716 |
N/A |
NDA |
NDA016295 |
H2-Pharma LLC |
HYDROXYUREA |
400 mg/1 |
60 CAPSULE in 1 BOTTLE (61269-404-60) |