← FDA Drug Approvals (Drugs@FDA)

CARBAMAZEPINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UMEDICA · Approved 2020-04-15

Drug application

FDA Application #

ANDA207798

Application type

Abbreviated New Drug Application (Generic)

Brand name

CARBAMAZEPINE

Generic name

CARBAMAZEPINE

Active ingredients

CARBAMAZEPINE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

UMEDICA

Manufacturer

NIVAGEN PHARMACEUTICALS, INC.

First approval

2020-04-15

Source

Authoritative

Drugs@FDA application overview

Machine

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