| NDC Code | 31722-316-31 |
|---|
| Package Description | 1 CARTON in 1 KIT (31722-316-31) / 1 BOTTLE, GLASS in 1 CARTON (31722-316-60) / 60 mL in 1 BOTTLE, GLASS |
|---|
| Product NDC | 31722-316 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Sirolimus |
|---|
| Non-Proprietary Name | Sirolimus |
|---|
| Dosage Form | SOLUTION |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20240916 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA215080 |
|---|
| Manufacturer | Camber Pharmaceuticals, Inc. |
|---|
| Substance Name | SIROLIMUS |
|---|
| Strength | 1 |
|---|
| Strength Unit | mg/mL |
|---|
| Pharmacy Classes | Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA] |
|---|