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DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN · Approved 2018-06-13

Drug application

FDA Application #
ANDA205947
Application type
Abbreviated New Drug Application (Generic)
Brand name
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
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
2018-06-13

Source

Authoritative
Drugs@FDA application overview
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