| NDC Code | 52427-834-01 |
|---|
| Package Description | 1 BOTTLE in 1 CARTON (52427-834-01) / 100 TABLET, FILM COATED in 1 BOTTLE |
|---|
| Product NDC | 52427-834 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Stalevo |
|---|
| Non-Proprietary Name | Carbidopa, Levodopa, And Entacapone |
|---|
| Dosage Form | TABLET, FILM COATED |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20201005 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA021485 |
|---|
| Manufacturer | Almatica Pharma LLC |
|---|
| Substance Name | CARBIDOPA; ENTACAPONE; LEVODOPA |
|---|
| Strength | 37.5; 200; 150 |
|---|
| Strength Unit | mg/1; mg/1; mg/1 |
|---|
| Pharmacy Classes | Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC] |
|---|