Details for New Drug Application (NDA): 210341
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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-five suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 210341
Tradename: | CARBIDOPA AND LEVODOPA |
Applicant: | Alembic |
Ingredient: | carbidopa; levodopa |
Patents: | 0 |
Suppliers and Packaging for NDA: 210341
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 210341 | ANDA | Alembic Pharmaceuticals Limited | 46708-332 | 46708-332-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-332-30) |
CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 210341 | ANDA | Alembic Pharmaceuticals Limited | 46708-332 | 46708-332-31 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-332-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 25MG;100MG | ||||
Approval Date: | Jun 5, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 50MG;200MG | ||||
Approval Date: | Jun 5, 2019 | TE: | AB | RLD: | No |
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