FDA.reportPublic FDA data

Application 201922

Type
NDA
Sponsor
JOURNEY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XIMINOMINOCYCLINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 45MG BASENoNo
002XIMINOMINOCYCLINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 67.5MG BASENoNo
003XIMINOMINOCYCLINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 90MG BASENoNo
004XIMINOMINOCYCLINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 112.5MG BASENoNo
005XIMINOMINOCYCLINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 135MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10631-330Ximinominocycline hydrochlorideSun Pharmaceutical Industries, IncNDACurrent
10631-331Ximinominocycline hydrochlorideSun Pharmaceutical Industries, IncNDACurrent
10631-332Ximinominocycline hydrochlorideSun Pharmaceutical Industries, IncNDACurrent
69489-121Ximinominocycline hydrochlorideJourney Medical CorporationNDACurrent
69489-122Ximinominocycline hydrochlorideJourney Medical CorporationNDACurrent
69489-123Ximinominocycline hydrochlorideJourney Medical CorporationNDACurrent
72143-221Minocycline Hydrochlorideminocycline hydrochlorideJG Pharma, Inc.NDACurrent
72143-221Minocycline Hydrochlorideminocycline hydrochlorideJG Pharma, Inc.NDACurrent
72143-222Minocycline Hydrochlorideminocycline hydrochlorideJG Pharma, Inc.NDACurrent
72143-222Minocycline Hydrochlorideminocycline hydrochlorideJG Pharma, Inc.NDACurrent
72143-223Minocycline Hydrochlorideminocycline hydrochlorideJG Pharma, Inc.NDACurrent
72143-223Minocycline Hydrochlorideminocycline hydrochlorideJG Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84945SUPPL 2026-02-05
84881SUPPL 2026-01-30
40092SUPPL2015-08-14
24404ORIG2013-08-13
22864ORIG2013-08-13
32147ORIG2012-07-13
19042ORIG2012-07-13