| NDC Code | 0378-8305-01 |
|---|
| Package Description | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8305-01) |
|---|
| Product NDC | 0378-8305 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Carbidopa, Levodopa And Entacapone |
|---|
| Non-Proprietary Name | Carbidopa, Levodopa And Entacapone |
|---|
| Dosage Form | TABLET, FILM COATED |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20131028 |
|---|
| End Marketing Date | 20220630 |
|---|
| Marketing Category Name | NDA AUTHORIZED GENERIC |
|---|
| Application Number | NDA021485 |
|---|
| Manufacturer | Mylan Pharmaceuticals Inc. |
|---|
| Substance Name | CARBIDOPA; ENTACAPONE; LEVODOPA |
|---|
| Strength | 50; 200; 200 |
|---|
| 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] |
|---|