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TYDEMY

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN · Approved 2017-12-12

Drug application

FDA Application #

ANDA205948

Application type

Abbreviated New Drug Application (Generic)

Brand name

TYDEMY

Generic name

DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM

Active ingredients

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

LUPIN

Manufacturer

Lupin Pharmaceuticals, Inc.

First approval

2017-12-12

Source

Authoritative

Drugs@FDA application overview

Machine

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