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Details for New Drug Application (NDA): 078536
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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