| NDC Code | 49884-948-72 |
|---|
| Package Description | 30 PACKET in 1 CARTON (49884-948-72) / 1 POWDER, FOR SOLUTION in 1 PACKET (49884-948-52) |
|---|
| Product NDC | 49884-948 |
|---|
| 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 | ANDA207207 |
|---|
| Manufacturer | ENDO USA, Inc. |
|---|
| Substance Name | SAPROPTERIN DIHYDROCHLORIDE |
|---|
| Strength | 100 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA] |
|---|