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Report / Drug application metadata

CARBAMAZEPINE

The application ANDA212524 lists 3 product formulations. Its sponsor is TORRENT. The product details below come from the application record, not a prescribing guide.

Which products are in this application?

CARBAMAZEPINE

Active ingredients
CARBAMAZEPINE 400MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Product number
003
Therapeutic equivalence code
AB

CARBAMAZEPINE

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

CARBAMAZEPINE

Active ingredients
CARBAMAZEPINE 200MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Product number
002
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
ANDA212524
Sponsor
TORRENT

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