Application 205555

Type
NDA
Sponsor
NOVATECH SA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STERITALCTALCPOWDER;INTRAPLEURAL2GM/VIALYesNo
002STERITALCTALCPOWDER;INTRAPLEURAL3GM/VIALYesNo
003STERITALCTALCPOWDER;INTRAPLEURAL4GM/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62327-222SteritalcTalcNovatech SANDACurrent
62327-222SteritalcTalcNovatech SANDACurrent
62327-333SteritalcTalcNovatech SANDACurrent
62327-333SteritalcTalcNovatech SANDACurrent
62327-444SteritalcTalcNovatech SANDACurrent
62327-444SteritalcTalcNovatech SANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82543SUPPL 2025-06-12
82532SUPPL 2025-06-11
49867ORIG2017-09-27
48284ORIG2017-05-08
48236ORIG2017-05-04