FDA.reportPublic FDA data

Application 215252

Type
NDA
Sponsor
EXELA PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDESOLUTION;INTRAVENOUS125MG/125ML (1MG/ML)NoNo
002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDESOLUTION;INTRAVENOUS250MG/250ML (1MG/1ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51754-3000DILTIAZEM HYDROCHLORIDEdiltiazem hydrochlorideExela Pharma Sciences,LLCNDACurrent
51754-3500DILTIAZEM HYDROCHLORIDEdiltiazem hydrochlorideExela Pharma Sciences,LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71706ORIG2022-08-04
69159ORIG2021-10-29
69156ORIG2021-10-29