FDA.reportPublic FDA data

Application 208910

Type
NDA
Sponsor
RXMTM THERAPS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FIRVANQ KITVANCOMYCIN HYDROCHLORIDEFOR SOLUTION;ORALEQ 25MG BASE/MLYesYes
002FIRVANQ KITVANCOMYCIN HYDROCHLORIDEFOR SOLUTION;ORALEQ 50MG BASE/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65628-015FIRVANQvancomycin hydrochlorideAzurity Pharmaceuticals, IncNDACurrent
65628-015FIRVANQVancomycin hydrochlorideCutisPharma, Inc.NDACurrent
65628-015FIRVANQVancomycin hydrochlorideCutisPharma, Inc.NDACurrent
65628-015FIRVANQvancomycin hydrochlorideAzurity Pharmaceuticals, IncNDACurrent
65628-016FIRVANQvancomycin hydrochlorideAzurity Pharmaceuticals, IncNDACurrent
65628-016FIRVANQvancomycin hydrochlorideAzurity Pharmaceuticals, IncNDACurrent
65628-016FIRVANQVancomycin hydrochlorideCutisPharma, Inc.NDACurrent
65628-016FIRVANQVancomycin hydrochlorideCutisPharma, Inc.NDACurrent
65628-204FIRVANQvancomycin hydrochlorideAzurity Pharmaceuticals, IncNDACurrent
65628-204FIRVANQVancomycin hydrochlorideCutisPharma, Inc.NDACurrent
65628-204FIRVANQvancomycin hydrochlorideAzurity Pharmaceuticals, IncNDACurrent
65628-204FIRVANQVancomycin hydrochlorideCutisPharma, Inc.NDACurrent
65628-204FIRVANQvancomycin hydrochlorideAzurity Pharmaceuticals, IncNDACurrent
65628-205FIRVANQVancomycin hydrochlorideCutisPharma, Inc.NDACurrent
65628-205FIRVANQvancomycin hydrochlorideAzurity Pharmaceuticals, IncNDACurrent
65628-205FIRVANQVancomycin hydrochlorideCutisPharma, Inc.NDACurrent
65628-205FIRVANQvancomycin hydrochlorideAzurity Pharmaceuticals, IncNDACurrent
65628-205FIRVANQvancomycin hydrochlorideAzurity Pharmaceuticals, IncNDACurrent
65628-206FIRVANQvancomycin hydrochlorideAzurity Pharmaceuticals, IncNDACurrent
65628-206FIRVANQVancomycin hydrochlorideCutisPharma, Inc.NDACurrent
65628-206FIRVANQvancomycin hydrochlorideAzurity Pharmaceuticals, IncNDACurrent
65628-206FIRVANQVancomycin hydrochlorideCutisPharma, Inc.NDACurrent
65628-206FIRVANQvancomycin hydrochlorideAzurity Pharmaceuticals, IncNDACurrent
65628-208FIRVANQvancomycin hydrochlorideAzurity Pharmaceuticals, IncNDACurrent
65628-208FIRVANQVancomycin hydrochlorideCutisPharma, Inc.NDACurrent
65628-208FIRVANQvancomycin hydrochlorideAzurity Pharmaceuticals, IncNDACurrent
65628-208FIRVANQVancomycin hydrochlorideCutisPharma, Inc.NDACurrent
65628-208FIRVANQvancomycin hydrochlorideAzurity Pharmaceuticals, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70182SUPPL2022-02-17
66049SUPPL2021-02-01
66032SUPPL2021-02-01
61296SUPPL2019-12-17
55860ORIG2018-10-10
52130ORIG2018-01-30
52084ORIG2018-01-30