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FDA NDA · NDA210132

BIJUVA

Sponsor: MAYNE PHARMA

APPLICATION
NDA210132
TYPE
NDA
ORIGINAL APPROVAL
2018-10-28
LATEST ACTION
2026-02-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

BIJUVA · ReferencePrescription
ESTRADIOL 0.5MG, PROGESTERONE 100MG · CAPSULE · ORAL
BIJUVA · ReferencePrescription
ESTRADIOL 1MG, PROGESTERONE 100MG · CAPSULE · ORAL

Approval history

2026-02-12Labeling · Supplement 13 · standard — Label ↗AP
2024-02-15Labeling · Supplement 11 · standard — Label ↗AP
2021-12-28Efficacy · Supplement 6 · standard — Label ↗AP
2021-06-22Labeling · Supplement 1 · standard — Letter ↗AP
2021-06-22Labeling · Supplement 3 · standard — Letter ↗AP
2018-10-28Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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