← FDA Drug Approvals (Drugs@FDA)
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
- Machine
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