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NORGESTIMATE AND ETHINYL ESTRADIOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NAARI PTE · Approved 2015-11-12

Drug application

FDA Application #
ANDA203870
Application type
Abbreviated New Drug Application (Generic)
Brand name
NORGESTIMATE AND ETHINYL ESTRADIOL
Generic name
NORGESTIMATE AND ETHINYL ESTRADIOL
Active ingredients
ETHINYL ESTRADIOL; NORGESTIMATE
Dosage form
TABLET
Route
ORAL-28
Marketing status
Discontinued
Sponsor
NAARI PTE
Manufacturer
Amneal Pharmaceuticals NY LLC
First approval
2015-11-12

Source

Authoritative
Drugs@FDA application overview
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