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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208352
Company: EVOFEM INC

Products on NDA 208352

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHEXX	CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE	1%;1.8%;0.4%	GEL;VAGINAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208352

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/22/2020	ORIG-1	Approval	Type 3 - New Dosage Form and Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208352s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208352Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/208352Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/21/2025	SUPPL-5	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208352Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208352Orig1s005ltr.pdf
02/08/2022	SUPPL-2	Labeling-Package Insert	Label (PDF) Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208352s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208352s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208325Orig1s002ltr.pdf

Labels for NDA 208352

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/21/2025	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208352Orig1s005lbl.pdf
04/21/2025	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208352Orig1s005lbl.pdf
02/08/2022	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208352s002lbl.pdf
02/08/2022	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208352s002lbl.pdf
05/22/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208352s000lbl.pdf

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