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Report / Drug application metadata

CARBIDOPA AND LEVODOPA

The application ANDA210341 lists 2 product formulations. Its sponsor is ALEMBIC. The product details below come from the application record, not a prescribing guide.

Which products are in this application?

CARBIDOPA AND LEVODOPA

Active ingredients
CARBIDOPA 50MG; LEVODOPA 200MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Product number
002
Therapeutic equivalence code
AB

CARBIDOPA AND LEVODOPA

Active ingredients
CARBIDOPA 25MG; LEVODOPA 100MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Product number
001
Therapeutic equivalence code
AB

How should this information be used?

An application can contain several product versions and a history of submissions. The details shown here do not establish current availability in a particular country or pharmacy, and a listed strength is not a recommended dose. Check the current approved product label for indications, contraindications, warnings and dosing.

This page does not infer a medicine's treatment uses from its name or regulatory status. Application metadata is evidence about the listed product, not evidence that it is suitable for an individual patient.

Kind
Drug application metadata
Identifier
ANDA210341
Sponsor
ALEMBIC

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