← FDA Drug Approvals (Drugs@FDA)

CARBAMAZEPINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TARO · Approved 2009-03-31

Drug application

FDA Application #

ANDA078115

Application type

Abbreviated New Drug Application (Generic)

Brand name

CARBAMAZEPINE

Generic name

CARBAMAZEPINE

Active ingredients

CARBAMAZEPINE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

TARO

Manufacturer

Sun Pharmaceutical Industries, Inc.

First approval

2009-03-31

Source

Authoritative

Drugs@FDA application overview

Machine

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