← FDA Drug Approvals (Drugs@FDA)

CARBAMAZEPINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX INC · Approved 2011-11-25

Drug application

FDA Application #

ANDA078986

Application type

Abbreviated New Drug Application (Generic)

Brand name

CARBAMAZEPINE

Generic name

CARBAMAZEPINE

Active ingredients

CARBAMAZEPINE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

APOTEX INC

Manufacturer

Apotex Corp.

First approval

2011-11-25

Source

Authoritative

Drugs@FDA application overview

Machine

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