← FDA Drug Approvals (Drugs@FDA)

CARBAMAZEPINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CSPC OUYI · Approved 2021-04-13

Drug application

FDA Application #

ANDA213311

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

CSPC OUYI

Manufacturer

Upsher-Smith Laboratories, LLC

First approval

2021-04-13

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown