Details for New Drug Application (NDA): 076521
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The generic ingredient in CARBIDOPA AND LEVODOPA is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 076521
Tradename: | CARBIDOPA AND LEVODOPA |
Applicant: | Impax Labs |
Ingredient: | carbidopa; levodopa |
Patents: | 0 |
Suppliers and Packaging for NDA: 076521
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 076521 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-2033 | 60219-2033-1 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60219-2033-1) |
CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 076521 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-2033 | 60219-2033-3 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (60219-2033-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 25MG;100MG | ||||
Approval Date: | May 14, 2004 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 50MG;200MG | ||||
Approval Date: | May 14, 2004 | TE: | AB | RLD: | No |
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