| 73289-0071-2 |
73289-0071 |
HUMAN PRESCRIPTION DRUG |
ZELVYSIA |
sapropterin dihydrochloride |
POWDER, FOR SOLUTION |
ORAL |
20250429 |
N/A |
ANDA |
ANDA218645 |
Aucta Pharmaceuticals, Inc. |
SAPROPTERIN DIHYDROCHLORIDE |
500 mg/1 |
30 PACKET in 1 CARTON (73289-0071-2) / 1 POWDER, FOR SOLUTION in 1 PACKET (73289-0071-1) |
| 73289-0070-2 |
73289-0070 |
HUMAN PRESCRIPTION DRUG |
ZELVYSIA |
SAPROPTERIN DIHYDROCHLORIDE |
POWDER, FOR SOLUTION |
ORAL |
20250429 |
N/A |
ANDA |
ANDA218645 |
Aucta Pharmaceuticals, Inc. |
SAPROPTERIN DIHYDROCHLORIDE |
100 mg/1 |
30 PACKET in 1 CARTON (73289-0070-2) / 1 POWDER, FOR SOLUTION in 1 PACKET (73289-0070-1) |