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PHILITH

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVAST LABS LTD · Approved 2011-12-22

Drug application

FDA Application #

ANDA090947

Application type

Abbreviated New Drug Application (Generic)

Brand name

PHILITH

Generic name

NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS

Active ingredients

ETHINYL ESTRADIOL; NORETHINDRONE

Dosage form

TABLET

Route

ORAL-28

Marketing status

Prescription

Sponsor

NOVAST LABS LTD

Manufacturer

Northstar Rx LLC

First approval

2011-12-22

Source

Authoritative

Drugs@FDA application overview

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