Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208352

PHEXXI (CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE)
1%;1.8%;0.4%
Marketing Status: Prescription
Active Ingredient: CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE
Proprietary Name: PHEXXI
Dosage Form; Route of Administration: GEL; VAGINAL
Strength: 1%;1.8%;0.4%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208352
Product Number: 001
Approval Date: May 22, 2020
Applicant Holder Full Name: EVOFEM INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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