DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 078536
NDA 078536 describes CARBIDOPA AND LEVODOPA, which is a drug marketed by Accord Hlthcare, Apotex, Impax Labs, Kv Pharm, Mylan, Sun Pharm Inds, Sun Pharma Global, Actavis Elizabeth, Apotex Inc, Idt Australia Ltd, Mayne Pharma, SCS, and Watson Labs, and is included in twenty-one NDAs. It is available from twenty-five suppliers. Additional details are available on the CARBIDOPA AND LEVODOPA profile page.
The generic ingredient in CARBIDOPA AND LEVODOPA is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
The generic ingredient in CARBIDOPA AND LEVODOPA is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 078536
| Tradename: | CARBIDOPA AND LEVODOPA |
| Applicant: | Sun Pharm Inds |
| Ingredient: | carbidopa; levodopa |
| Patents: | 0 |
| Therapeutic Class: | Antiparkinson Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078536
| Ingredient-type | Amino Acids, Aromatic |
Suppliers and Packaging for NDA: 078536
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET;ORAL | 078536 | ANDA | Unit Dose Services | 50436-6753 | N | 50436-6753-2 |
| CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET;ORAL | 078536 | ANDA | Unit Dose Services | 50436-6753 | N | 50436-6753-1 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;100MG | ||||
| Approval Date: | Oct 28, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;100MG | ||||
| Approval Date: | Oct 28, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;250MG | ||||
| Approval Date: | Oct 28, 2008 | TE: | AB | RLD: | No | ||||
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