← FDA Drug Approvals (Drugs@FDA)
BIJUVA
NDA · New Drug Application · Sponsor: MAYNE PHARMA · Approved 2018-10-28
Drug application
- FDA Application #
NDA210132
- Application type
- New Drug Application
- Brand name
- BIJUVA
- Generic name
- ESTRADIOL AND PROGESTERONE
- Active ingredients
- ESTRADIOL; PROGESTERONE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- MAYNE PHARMA
- Manufacturer
- Mayne Pharma
- First approval
- 2018-10-28
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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