FDA.reportPublic FDA data

Application 205931

Type
NDA
Sponsor
ALMIRALL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACTICLATEDOXYCYCLINE HYCLATETABLET;ORALEQ 75MG BASEYesNo
002ACTICLATEDOXYCYCLINE HYCLATETABLET;ORALEQ 150MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-6100Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.NDACurrent
0591-6100Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.NDACurrent
0591-6100Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.NDACurrent
0591-6100Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.NDACurrent
0591-6125Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.NDACurrent
0591-6125Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.NDACurrent
0591-6125Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.NDACurrent
0591-6125Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.NDACurrent
16110-501Acticlatedoxycycline hyclateAlmirall, LLCNDACurrent
16110-501Acticlatedoxycycline hyclateAlmirall, LLCNDACurrent
16110-501Acticlatedoxycycline hyclateAqua PharmaceuticalsNDACurrent
16110-501Acticlatedoxycycline hyclateAlmirall, LLCNDACurrent
16110-502Acticlatedoxycycline hyclateAlmirall, LLCNDACurrent
16110-502Acticlatedoxycycline hyclateAlmirall, LLCNDACurrent
16110-502Acticlatedoxycycline hyclateAqua PharmaceuticalsNDACurrent
16110-502Acticlatedoxycycline hyclateAlmirall, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81858SUPPL 2025-04-08
81802SUPPL 2025-04-02
62049SUPPL2020-03-05
62044SUPPL2020-03-05
61495SUPPL2020-01-02
61464SUPPL2019-12-27
50519SUPPL2017-11-29
50416SUPPL2017-11-15
32768SUPPL2016-04-28
40521SUPPL2016-04-27
43507ORIG2014-12-18
32767ORIG2014-07-28
19699ORIG2014-07-28