← FDA Drug Approvals (Drugs@FDA)

INTROVALE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: XIROMED · Approved 2010-09-27

Drug application

FDA Application #

ANDA079064

Application type

Abbreviated New Drug Application (Generic)

Brand name

INTROVALE

Generic name

LEVONORGESTREL AND ETHINYL ESTRADIOL

Active ingredients

ETHINYL ESTRADIOL; LEVONORGESTREL

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

XIROMED

Manufacturer

Xiromed, LLC.

First approval

2010-09-27

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown