FDA.reportPublic FDA data

Application 208264

Type
NDA
Sponsor
ADIENNE SA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEPADINATHIOTEPAPOWDER;INTRAVENOUS15MG/VIALYesYes
002TEPADINATHIOTEPAPOWDER;INTRAVENOUS100MG/VIALYesYes
003TEPADINA AND SODIUM CHLORIDETHIOTEPAPOWDER;INTRAVENOUS200MGYesYes
004TEPADINA AND SODIUM CHLORIDETHIOTEPAPOWDER;INTRAVENOUS400MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53964-001TEPADINATHIOTEPAADIENNE SANDACurrent
53964-002TEPADINATHIOTEPAADIENNE SANDACurrent
70121-1630TEPADINATHIOTEPAAmneal Pharmaceuticals LLCNDACurrent
70121-1630TEPADINATHIOTEPAAmneal Pharmaceuticals LLCNDACurrent
70121-1630TEPADINATHIOTEPAAmneal Biosciences LLCNDACurrent
70121-1630TEPADINATHIOTEPAAmneal Biosciences LLCNDACurrent
70121-1630TEPADINATHIOTEPAAmneal Biosciences LLCNDACurrent
70121-1630TEPADINATHIOTEPAAmneal Pharmaceuticals LLCNDACurrent
70121-1630TEPADINATHIOTEPAAmneal Pharmaceuticals LLCNDACurrent
70121-1631TEPADINATHIOTEPAAmneal Pharmaceuticals LLCNDACurrent
70121-1631TEPADINATHIOTEPAAmneal Pharmaceuticals LLCNDACurrent
70121-1631TEPADINATHIOTEPAAmneal Biosciences LLCNDACurrent
70121-1631TEPADINATHIOTEPAAmneal Biosciences LLCNDACurrent
70121-1631TEPADINATHIOTEPAAmneal Biosciences LLCNDACurrent
70121-1631TEPADINATHIOTEPAAmneal Pharmaceuticals LLCNDACurrent
70121-1631TEPADINATHIOTEPAAmneal Pharmaceuticals LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85468SUPPL 2026-03-23
85467SUPPL 2026-03-23
85466SUPPL 2026-03-23
85465SUPPL 2026-03-23
85464SUPPL 2026-03-23
85462SUPPL 2026-03-23
74327SUPPL 2023-05-23
74322SUPPL 2023-05-19
61481SUPPL2019-12-31
54776ORIG2018-07-06
47010ORIG2017-01-30
46992ORIG2017-01-26