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ESTRADIOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2023-09-06

Drug application

FDA Application #
ANDA217334
Application type
Abbreviated New Drug Application (Generic)
Brand name
ESTRADIOL
Generic name
ESTRADIOL
Active ingredients
ESTRADIOL
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
NOVITIUM PHARMA
Manufacturer
ANI Pharmaceuticals, Inc.
First approval
2023-09-06

Source

Authoritative
Drugs@FDA application overview
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