← FDA Drug Approvals (Drugs@FDA)

DROSPIRENONE AND ETHINYL ESTRADIOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN LTD · Approved 2012-12-18

Drug application

FDA Application #

ANDA201663

Application type

Abbreviated New Drug Application (Generic)

Brand name

DROSPIRENONE AND ETHINYL ESTRADIOL

Generic name

DROSPIRENONE AND ETHINYL ESTRADIOL

Active ingredients

DROSPIRENONE; ETHINYL ESTRADIOL

Dosage form

TABLET

Route

ORAL-28

Marketing status

Prescription

Sponsor

LUPIN LTD

Manufacturer

Lupin Pharmaceuticals, Inc.

First approval

2012-12-18

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown