← FDA Drug Approvals (Drugs@FDA)
KELNOR
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: BARR · Approved 2005-05-23
Drug application
- FDA Application #
ANDA076785
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- KELNOR
- Generic name
- ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL
- Active ingredients
- ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE
- Dosage form
- TABLET
- Route
- ORAL-28
- Marketing status
- Prescription
- Sponsor
- BARR
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- First approval
- 2005-05-23
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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