FDA.reportPublic FDA data

Application 209521

Type
NDA
Sponsor
ALMIRALL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SEYSARASARECYCLINE HYDROCHLORIDETABLET;ORALEQ 60MG BASEYesNo
002SEYSARASARECYCLINE HYDROCHLORIDETABLET;ORALEQ 100MG BASEYesNo
003SEYSARASARECYCLINE HYDROCHLORIDETABLET;ORALEQ 150MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16110-245Seysarasarecycline hydrochlorideAlmirall, LLCNDACurrent
16110-245Seysarasarecycline hydrochlorideAlmirall, LLCNDACurrent
16110-245Seysarasarecycline hydrochlorideAlmirall, LLCNDACurrent
16110-245Seysarasarecycline hydrochlorideAlmirall, LLCNDACurrent
16110-246Seysarasarecycline hydrochlorideAlmirall, LLCNDACurrent
16110-246Seysarasarecycline hydrochlorideAlmirall, LLCNDACurrent
16110-246Seysarasarecycline hydrochlorideAlmirall, LLCNDACurrent
16110-246Seysarasarecycline hydrochlorideAlmirall, LLCNDACurrent
16110-247Seysarasarecycline hydrochlorideAlmirall, LLCNDACurrent
16110-247Seysarasarecycline hydrochlorideAlmirall, LLCNDACurrent
16110-247Seysarasarecycline hydrochlorideAlmirall, LLCNDACurrent
16110-247Seysarasarecycline hydrochlorideAlmirall, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73918SUPPL 2023-03-31
73917SUPPL 2023-03-31
73914SUPPL 2023-03-31
73913SUPPL 2023-03-31
63404SUPPL2020-06-02
63402SUPPL2020-06-02
58275SUPPL2019-04-10
58268SUPPL2019-04-10
56012ORIG2018-10-18
55785ORIG2018-10-02
55784ORIG2018-10-01
63265ORIG1900-01-01