FDA.reportPublic FDA data

Application 050641

Type
NDA
Sponsor
ALMIRALL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MONODOXDOXYCYCLINECAPSULE;ORALEQ 100MG BASEYesNo
002MONODOXDOXYCYCLINECAPSULE;ORALEQ 50MG BASEYesNo
003MONODOXDOXYCYCLINECAPSULE;ORALEQ 75MG BASEYesNo
004MONODOXDOXYCYCLINECAPSULE;ORALEQ 150MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-0410Doxycycline MonohydrateDoxycyclineActavis Pharma, Inc.NDA AUTHORIZED Current
0591-0410Doxycycline MonohydrateDoxycyclineActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-0411Doxycycline MonohydrateDoxycyclineActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-0411Doxycycline MonohydrateDoxycyclineActavis Pharma, Inc.NDA AUTHORIZED Current
0591-2404Doxycycline MonohydrateDoxycyclineActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2404Doxycycline MonohydrateDoxycyclineActavis Pharma, Inc.NDA AUTHORIZED Current
16110-075MonodoxdoxycyclineAqua Pharmaceuticals, LLCNDACurrent
16110-259MonodoxdoxycyclineAqua Pharmaceuticals, LLCNDACurrent
16110-260MonodoxdoxycyclineAqua Pharmaceuticals, LLCNDACurrent
43063-529Doxycycline MonohydrateDoxycyclinePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-789Doxycycline MonohydrateDoxycyclinePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-789Doxycycline MonohydrateDoxycyclinePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
53002-0671Doxycycline MonohydrateDoxycyclineRPK Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62135-260Doxycycline MonohydrateDoxycycline MonohydrateChartwell RX, LLC.NDACurrent
62135-260Doxycycline MonohydrateDoxycycline MonohydrateChartwell RX, LLC.NDACurrent
62135-260Doxycycline MonohydrateDoxycycline MonohydrateChartwell RX, LLC.NDACurrent
62135-260Doxycycline MonohydrateDoxycycline MonohydrateChartwell RX, LLC.NDACurrent
62135-260Doxycycline MonohydrateDoxycycline MonohydrateChartwell RX, LLC.NDACurrent
62135-261Doxycycline MonohydrateDoxycycline MonohydrateChartwell RX, LLC.NDACurrent
62135-261Doxycycline MonohydrateDoxycycline MonohydrateChartwell RX, LLC.NDACurrent
62135-261Doxycycline MonohydrateDoxycycline MonohydrateChartwell RX, LLC.NDACurrent
62135-261Doxycycline MonohydrateDoxycycline MonohydrateChartwell RX, LLC.NDACurrent
62135-261Doxycycline MonohydrateDoxycycline MonohydrateChartwell RX, LLC.NDACurrent
62135-262Doxycycline MonohydrateDoxycycline MonohydrateChartwell RX, LLC.NDACurrent
62135-262Doxycycline MonohydrateDoxycycline MonohydrateChartwell RX, LLC.NDACurrent
62135-262Doxycycline MonohydrateDoxycycline MonohydrateChartwell RX, LLC.NDACurrent
62135-262Doxycycline MonohydrateDoxycycline MonohydrateChartwell RX, LLC.NDACurrent
62135-262Doxycycline MonohydrateDoxycycline MonohydrateChartwell RX, LLC.NDACurrent
62135-263Doxycycline MonohydrateDoxycycline MonohydrateChartwell RX, LLC.NDACurrent
62135-263Doxycycline MonohydrateDoxycycline MonohydrateChartwell RX, LLC.NDACurrent
62135-263Doxycycline MonohydrateDoxycycline MonohydrateChartwell RX, LLC.NDACurrent
63629-5361Doxycycline MonohydrateDoxycyclineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
67296-1578Doxycycline MonohydrateDoxycycline MonohydrateRedPharm Drug, Inc.NDACurrent
67296-1578Doxycycline MonohydrateDoxycycline MonohydrateRedPharm Drug, Inc.NDACurrent
71610-220Doxycycline MonohydrateDoxycyclineAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81852SUPPL 2025-04-08
81794SUPPL 2025-04-02
78451SUPPL 2024-05-14
78444SUPPL 2024-05-09
70202SUPPL2022-02-22
70190SUPPL2022-02-18
47870SUPPL2017-04-05
47852SUPPL2017-04-04
17969SUPPL2013-10-17
7926SUPPL2013-10-15
39067SUPPL2012-01-23
30216SUPPL2012-01-17
17968SUPPL2011-03-11
7925SUPPL2011-03-10
30215SUPPL2008-01-09
17967SUPPL2008-01-08
7924SUPPL2007-02-12
30214SUPPL2002-06-18
30213SUPPL2002-03-21