Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 210132

Expand all

BIJUVA (ESTRADIOL; PROGESTERONE)
0.5MG;100MG
Marketing Status: Prescription

Active Ingredient: ESTRADIOL; PROGESTERONE
Proprietary Name: BIJUVA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.5MG;100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210132
Product Number: 002
Approval Date: Dec 28, 2021
Applicant Holder Full Name: MAYNE PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

BIJUVA (ESTRADIOL; PROGESTERONE)
1MG;100MG
Marketing Status: Prescription

Active Ingredient: ESTRADIOL; PROGESTERONE
Proprietary Name: BIJUVA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1MG;100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210132
Product Number: 001
Approval Date: Oct 28, 2018
Applicant Holder Full Name: MAYNE PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information