← FDA Drug Approvals (Drugs@FDA)

CYCLAFEM 0.5/35

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2015-12-16

Drug application

FDA Application #

ANDA203413

Application type

Abbreviated New Drug Application (Generic)

Brand name

CYCLAFEM 0.5/35

Generic name

Ethinyl Estradiol

Active ingredients

ETHINYL ESTRADIOL; NORETHINDRONE

Dosage form

TABLET

Route

ORAL-28

Marketing status

Discontinued

Sponsor

PH HEALTH

First approval

2015-12-16

Source

Authoritative

Drugs@FDA application overview

Machine

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