← FDA Drug Approvals (Drugs@FDA)

TEMOZOLOMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACCORD HLTHCARE · Approved 2017-02-27

Drug application

FDA Application #

ANDA201528

Application type

Abbreviated New Drug Application (Generic)

Brand name

TEMOZOLOMIDE

Generic name

TEMOZOLOMIDE

Active ingredients

TEMOZOLOMIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

ACCORD HLTHCARE

Manufacturer

Accord Healthcare Inc.

First approval

2017-02-27

Source

Authoritative

Drugs@FDA application overview

Machine

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