← FDA Drug Approvals (Drugs@FDA)

KAITLIB FE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN · Approved 2015-12-17

Drug application

FDA Application #

ANDA203448

Application type

Abbreviated New Drug Application (Generic)

Brand name

KAITLIB FE

Generic name

NORETHINDRONE AND ETHINYL ESTRADIOL

Active ingredients

ETHINYL ESTRADIOL; NORETHINDRONE

Dosage form

TABLET, CHEWABLE

Route

ORAL

Marketing status

Prescription

Sponsor

LUPIN

Manufacturer

Lupin Pharmaceuticals, Inc.

First approval

2015-12-17

Source

Authoritative

Drugs@FDA application overview

Machine

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