| NDC Code | 43598-096-05 |
|---|
| Package Description | 500 TABLET in 1 BOTTLE (43598-096-05) |
|---|
| Product NDC | 43598-096 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Javygtor |
|---|
| Non-Proprietary Name | Sapropterin Dihydrochloride |
|---|
| Dosage Form | TABLET |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20221003 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA207685 |
|---|
| Manufacturer | Dr. Reddys Laboratories 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] |
|---|