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ETHINYL ESTRADIOL AND NORELGESTROMIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2023-09-14

Drug application

FDA Application #
ANDA214594
Application type
Abbreviated New Drug Application (Generic)
Brand name
ETHINYL ESTRADIOL AND NORELGESTROMIN
Generic name
NORELGESTROMIN AND ETHINYL ESTRADIOL
Active ingredients
ETHINYL ESTRADIOL; NORELGESTROMIN
Dosage form
FILM, EXTENDED RELEASE
Route
TRANSDERMAL
Marketing status
Prescription
Sponsor
ZYDUS PHARMS
Manufacturer
Zydus Pharmaceuticals USA Inc.
First approval
2023-09-14

Source

Authoritative
Drugs@FDA application overview
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