Stalevo is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Almatica Pharma Llc. The primary component is Carbidopa; Levodopa; Entacapone.
Product ID | 52427-805_2d07b1db-c94b-7d26-2652-16f32b3bc67b |
NDC | 52427-805 |
Product Type | Human Prescription Drug |
Proprietary Name | Stalevo |
Generic Name | Carbidopa, Levodopa, And Entacapone |
Dosage Form | Tablet, Film Coated |
Route of Administration | ORAL |
Marketing Start Date | 2020-10-05 |
Marketing Category | NDA / NDA |
Application Number | NDA021485 |
Labeler Name | Almatica Pharma LLC |
Substance Name | CARBIDOPA; LEVODOPA; ENTACAPONE |
Active Ingredient Strength | 13 mg/1; mg/1; mg/1 |
Pharm Classes | Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2022-12-31 |
Marketing Start Date | 2020-10-05 |
NDC Exclude Flag | N |
Sample Package? | N |
NDC | Brand Name | Generic Name |
---|---|---|
0078-0407 | Stalevo | carbidopa, levodopa, and entacapone |
0078-0408 | Stalevo | carbidopa, levodopa, and entacapone |
0078-0409 | Stalevo | carbidopa, levodopa, and entacapone |
0078-0527 | Stalevo | carbidopa, levodopa, and entacapone |
0078-0544 | Stalevo | carbidopa, levodopa, and entacapone |
0078-0545 | Stalevo | carbidopa, levodopa, and entacapone |
52427-805 | Stalevo | carbidopa, levodopa, and entacapone |
52427-809 | Stalevo | carbidopa, levodopa, and entacapone |
52427-816 | Stalevo | carbidopa, levodopa, and entacapone |
52427-827 | Stalevo | carbidopa, levodopa, and entacapone |
52427-834 | Stalevo | carbidopa, levodopa, and entacapone |
52427-842 | Stalevo | Stalevo |
0781-5613 | Carbidopa, Levodopa, and Entacapone | Carbidopa, Levodopa, and Entacapone |
0781-5625 | Carbidopa, Levodopa, and Entacapone | Carbidopa, Levodopa, and Entacapone |
0781-5637 | Carbidopa, Levodopa, and Entacapone | Carbidopa, Levodopa, and Entacapone |
0781-5641 | Carbidopa, Levodopa, and Entacapone | Carbidopa, Levodopa, and Entacapone |
0781-5654 | Carbidopa, Levodopa, and Entacapone | Carbidopa, Levodopa, and Entacapone |
0781-5669 | Carbidopa, Levodopa, and Entacapone | Carbidopa, Levodopa, and Entacapone |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
STALEVO 76431957 2799827 Live/Registered |
Orion Corporation 2002-07-16 |