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LEVONORGESTREL AND ETHINYL ESTRADIOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DR REDDYS LABS SA · Approved 2004-11-18

Drug application

FDA Application #
ANDA076625
Application type
Abbreviated New Drug Application (Generic)
Brand name
LEVONORGESTREL AND ETHINYL ESTRADIOL
Generic name
LEVONORGESTREL AND ETHINYL ESTRADIOL
Active ingredients
ETHINYL ESTRADIOL; LEVONORGESTREL
Dosage form
TABLET
Route
ORAL-28
Marketing status
Prescription
Sponsor
DR REDDYS LABS SA
Manufacturer
Mayne Pharma Inc.
First approval
2004-11-18

Source

Authoritative
Drugs@FDA application overview
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