Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208564

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IMVEXXY (ESTRADIOL)
0.004MG
Marketing Status: Prescription

Active Ingredient: ESTRADIOL
Proprietary Name: IMVEXXY
Dosage Form; Route of Administration: INSERT; VAGINAL
Strength: 0.004MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208564
Product Number: 001
Approval Date: May 29, 2018
Applicant Holder Full Name: MAYNE PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

IMVEXXY (ESTRADIOL)
0.01MG
Marketing Status: Prescription

Active Ingredient: ESTRADIOL
Proprietary Name: IMVEXXY
Dosage Form; Route of Administration: INSERT; VAGINAL
Strength: 0.01MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208564
Product Number: 002
Approval Date: May 29, 2018
Applicant Holder Full Name: MAYNE PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information