FDA.reportPublic FDA data

Application 215000

Type
NDA
Sponsor
ACCORD HLTHCARE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARMUSTINECARMUSTINEINJECTABLE;INJECTION50MG/VIALNoNo
002CARMUSTINECARMUSTINEPOWDER;INTRAVENOUS300MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-545CARMUSTINECARMUSTINEAccord Healthcare Inc.NDACurrent
16729-545CARMUSTINECARMUSTINEAccord Healthcare Inc.NDACurrent
16729-548CARMUSTINECARMUSTINEAccord Healthcare Inc.NDACurrent
16729-548CARMUSTINECARMUSTINEAccord Healthcare Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72587ORIG2022-11-10
71088ORIG2022-05-17
71084ORIG2022-05-17