← FDA DRUG APPROVALS

FDA NDA · NDA208352

PHEXXI

lactic acid, l-, citric acid monohydrate, and potassium bitartrate

Sponsor: EVOFEM INC

APPLICATION
NDA208352
TYPE
NDA
ORIGINAL APPROVAL
2020-05-22
LATEST ACTION
2025-04-21
ROUTE
VAGINAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

PHEXX · ReferencePrescription
CITRIC ACID 1%, LACTIC ACID 1.8%, POTASSIUM BITARTRATE 0.4% · GEL · VAGINAL

Approval history

2025-04-21Labeling · Supplement 5 · standard — Label ↗AP
2022-02-08Labeling · Supplement 2 · standard — Letter ↗AP
2020-05-22Type 3 - New Dosage Form and Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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