Details for New Drug Application (NDA): 208352

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NDA 208352 describes PHEXXI, which is a drug marketed by Evofem Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the PHEXXI profile page.

The generic ingredient in PHEXXI is citric acid; lactic acid; potassium bitartrate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the citric acid; lactic acid; potassium bitartrate profile page.

Summary for 208352

Tradename:	PHEXXI
Applicant:	Evofem Inc
Ingredient:	citric acid; lactic acid; potassium bitartrate
Patents:	5

Pharmacology for NDA: 208352

Mechanism of Action	Acidifying Activity Calcium Chelating Activity
Physiological Effect	Decreased Coagulation Factor Activity

Suppliers and Packaging for NDA: 208352

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352	NDA	Evofem, Inc.	69751-100	69751-100-03	3 APPLICATOR in 1 BOX (69751-100-03) / 5 g in 1 APPLICATOR (69751-100-01)
PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352	NDA	Evofem, Inc.	69751-100	69751-100-12	12 APPLICATOR in 1 BOX (69751-100-12) / 5 g in 1 APPLICATOR (69751-100-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;VAGINAL			Strength	1%;1.8%;0.4%
Approval Date:	May 22, 2020	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Mar 15, 2033	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	PREVENTION OF PREGNANCY
Patent:	⤷ Sign Up	Patent Expiration:	Mar 15, 2033	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	PREVENTION OF PREGNANCY
Patent:	⤷ Sign Up	Patent Expiration:	Mar 15, 2033	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 208352

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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