NDC Code | 0378-8303-01 |
Package Description | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8303-01) |
Product NDC | 0378-8303 |
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 | 20220228 |
Marketing Category Name | NDA AUTHORIZED GENERIC |
Application Number | NDA021485 |
Manufacturer | Mylan Pharmaceuticals Inc. |
Substance Name | CARBIDOPA; ENTACAPONE; LEVODOPA |
Strength | 31.25; 200; 125 |
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] |