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FDA Drug Approval, N210132, BIJUVA
FDA Drug Approval, N210132, BIJUVA
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NDA: 210132
Company: MAYNE PHARMA
Drug Name: BIJUVA
Active Ingredients: ESTRADIOL; PROGESTERONE
Strength: 0.5MG;100MG
Dosage Form/Route: CAPSULE;ORAL
Action Date: 10/28/2018
Marketing Status: Prescription
Submission Classification: Type 4 - New Combination
Company: MAYNE PHARMA
Drug Name: BIJUVA
Active Ingredients: ESTRADIOL; PROGESTERONE
Strength: 0.5MG;100MG
Dosage Form/Route: CAPSULE;ORAL
Action Date: 10/28/2018
Marketing Status: Prescription
Submission Classification: Type 4 - New Combination
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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