← FDA Drug Approvals (Drugs@FDA)

HAILEY 1.5/30

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLENMARK SPECLT · Approved 2018-06-05

Drug application

FDA Application #

ANDA209297

Application type

Abbreviated New Drug Application (Generic)

Brand name

HAILEY 1.5/30

Generic name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Active ingredients

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Dosage form

TABLET

Route

ORAL-21

Marketing status

Prescription

Sponsor

GLENMARK SPECLT

Manufacturer

Glenmark Pharmaceuticals Inc., USA

First approval

2018-06-05

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown