← FDA Drug Approvals (Drugs@FDA)

CARBATROL

NDA · New Drug Application · Sponsor: TAKEDA PHARMS USA · Approved 1997-09-30

Drug application

FDA Application #

NDA020712

Application type

New Drug Application

Brand name

CARBATROL

Generic name

CARBAMAZEPINE

Active ingredients

CARBAMAZEPINE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

TAKEDA PHARMS USA

Manufacturer

Takeda Pharmaceuticals America, Inc.

First approval

1997-09-30

Source

Authoritative

Drugs@FDA application overview

Machine

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