← FDA Drug Approvals (Drugs@FDA)
WERA
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVAST LABS LTD · Approved 2012-03-27
Drug application
- FDA Application #
ANDA091204
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- WERA
- Generic name
- NORETHINDRONE AND ETHINYL ESTRADIOL
- Active ingredients
- ETHINYL ESTRADIOL; NORETHINDRONE
- Dosage form
- TABLET
- Route
- ORAL-28
- Marketing status
- Prescription
- Sponsor
- NOVAST LABS LTD
- Manufacturer
- Northstar Rx LLC
- First approval
- 2012-03-27
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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