BIJUVA (ESTRADIOL AND PROGESTERONE)
Summary
FDA approved BIJUVA (ESTRADIOL AND PROGESTERONE) by MAYNE PHARMA. NDA (New Drug) approval (Labeling) on 2026-02-12. CAPSULE, ORAL.
Details
Source
Drug Approval
External ID
NDA210132-13
Action Date
2026-02-12
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
BIJUVA (generic: ESTRADIOL AND PROGESTERONE), CAPSULE, ORAL. Application: NDA210132
Company
Context & Analysis
MAYNE PHARMA has 4 FDA actions in our database.
Frequently Asked Questions
How often does MAYNE PHARMA have FDA actions?
MAYNE PHARMA has 4 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA210132-13" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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