Application 208352

Type
NDA
Sponsor
EVOFEM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHEXXILACTIC ACID;CITRIC ACID;POTASSIUM BITARTRATEGEL;VAGINAL5GYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69751-100Phexxilactic acid, L-, citric acid monohydrate, and potassium bitartrateEvofem, Inc.NDACurrent
69751-100Phexxilactic acid, L-, citric acid monohydrate, and potassium bitartrateEvofem, Inc.NDACurrent
69751-100Phexxilactic acid, L-, citric acid monohydrate, and potassium bitartrateEvofem, Inc.NDACurrent
69751-100Phexxilactic acid, L-, citric acid monohydrate, and potassium bitartrateEvofem, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81986SUPPL 2026-04-14
81992SUPPL 2025-04-25
70145SUPPL2022-02-11
70144SUPPL2022-02-10
70134SUPPL2022-02-09
65146ORIG2020-11-03
63318ORIG2020-05-28
63278ORIG2020-05-22