Details for New Drug Application (NDA): 208352
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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: | ⤷ Subscribe | Patent Expiration: | Mar 15, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | PREVENTION OF PREGNANCY | ||||||||
Patent: | ⤷ Subscribe | Patent Expiration: | Mar 15, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | PREVENTION OF PREGNANCY | ||||||||
Patent: | ⤷ Subscribe | Patent Expiration: | Mar 15, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
Expired US Patents for NDA 208352
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 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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