← FDA Drug Approvals (Drugs@FDA)
DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: XIROMED · Approved 2015-05-04
Drug application
- FDA Application #
ANDA202131- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DROSPIRENONE AND ETHINYL ESTRADIOL
- Generic name
- DROSPIRENONE AND ETHINYL ESTRADIOL
- Active ingredients
- DROSPIRENONE; ETHINYL ESTRADIOL
- Dosage form
- TABLET
- Route
- ORAL-28
- Marketing status
- Prescription
- Sponsor
- XIROMED
- Manufacturer
- Mylan Pharmaceuticals Inc.
- First approval
- 2015-05-04
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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