FDA.reportPublic FDA data

Application 019821

Type
NDA
Sponsor
STIEFEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SORIATANEACITRETINCAPSULE;ORAL10MGYesNo
002SORIATANEACITRETINCAPSULE;ORAL25MGYesYes
003SORIATANEACITRETINCAPSULE;ORAL17.5MGYesNo
004SORIATANEACITRETINCAPSULE;ORAL22.5MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0145-0090SORIATANEacitretinStiefel Laboratories IncNDACurrent
0145-0090SORIATANEacitretinStiefel Laboratories IncNDACurrent
0145-0090SORIATANEacitretinStiefel Laboratories IncNDACurrent
0145-0090SORIATANEacitretinStiefel Laboratories IncNDACurrent
0145-0090SORIATANEacitretinStiefel Laboratories IncNDACurrent
0145-0091SORIATANEacitretinStiefel Laboratories IncNDACurrent
0145-0091SORIATANEacitretinStiefel Laboratories IncNDACurrent
0145-0091SORIATANEacitretinStiefel Laboratories IncNDACurrent
0145-0091SORIATANEacitretinStiefel Laboratories IncNDACurrent
0145-0091SORIATANEacitretinStiefel Laboratories IncNDACurrent
66993-894ACITRETINacitretinPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-894ACITRETINacitretinPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-894ACITRETINacitretinPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-896ACITRETINacitretinPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-896ACITRETINacitretinPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-896ACITRETINacitretinPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73600SUPPL 2023-02-23
73599SUPPL 2023-02-23
73596SUPPL 2023-02-23
49886SUPPL2017-09-29
49873SUPPL2017-09-28
1652SUPPL2015-05-22
11744SUPPL2015-05-21
19264SUPPL2014-05-19
11743SUPPL2014-05-15
1651SUPPL2014-02-20
11742SUPPL2014-02-19
19263SUPPL2014-02-04
33989SUPPL2014-01-31
43628SUPPL2011-11-29
33988SUPPL2011-11-29
1650SUPPL2011-11-28
19262SUPPL2010-02-16
33987SUPPL2007-10-22
19261SUPPL2007-10-22
11741SUPPL2007-10-22
1649SUPPL2007-10-22
41044SUPPL2007-07-06
20378SUPPL2007-07-06
1648SUPPL2004-11-08
33986SUPPL2004-10-15
1647SUPPL2004-10-15
33985SUPPL2004-04-05
19260SUPPL2004-03-24
19259SUPPL2003-05-29
1646SUPPL2003-05-29
33984SUPPL2003-04-28
11740SUPPL2003-04-28
20377SUPPL1997-06-05