NDC Code | 49884-873-72 |
Package Description | 30 PACKET in 1 CARTON (49884-873-72) / 1 POWDER, FOR SOLUTION in 1 PACKET (49884-873-52) |
Product NDC | 49884-873 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Sapropterin Dihydrochloride |
Non-Proprietary Name | Sapropterin Dihydrochloride |
Dosage Form | POWDER, FOR SOLUTION |
Usage | ORAL |
Start Marketing Date | 20201001 |
Marketing Category Name | ANDA |
Application Number | ANDA210027 |
Manufacturer | ENDO USA, Inc. |
Substance Name | SAPROPTERIN DIHYDROCHLORIDE |
Strength | 500 |
Strength Unit | mg/1 |
Pharmacy Classes | Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA] |