← FDA Drug Approvals (Drugs@FDA)
BALCOLTRA
NDA · New Drug Application · Sponsor: AVION PHARMS · Approved 2018-01-09
Drug application
- FDA Application #
NDA208612- Application type
- New Drug Application
- Brand name
- BALCOLTRA
- Generic name
- LEVONORGESTREL AND ETHINYL ESTRADIOL
- Active ingredients
- ETHINYL ESTRADIOL; LEVONORGESTREL
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AVION PHARMS
- Manufacturer
- Avion Pharmaceuticals
- First approval
- 2018-01-09
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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