FDA.reportPublic FDA data

Application 020457

Type
NDA
Sponsor
CHEPLAPHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ETOPOPHOS PRESERVATIVE FREEETOPOSIDE PHOSPHATEINJECTABLE;INJECTIONEQ 100MG BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0015-3404ETOPOPHOSetoposide phosphateE.R. Squibb & Sons, L.L.C.NDACurrent
0015-3404ETOPOPHOSetoposide phosphateE.R. Squibb & Sons, L.L.CNDACurrent
0015-3404ETOPOPHOSetoposide phosphateE.R. Squibb & Sons, L.L.C.NDACurrent
0015-3404ETOPOPHOSetoposide phosphateE.R. Squibb & Sons, L.L.C.NDACurrent
0015-3404ETOPOPHOSetoposide phosphateE.R. Squibb & Sons, L.L.C.NDACurrent
61269-410ETOPOPHOSetoposide phosphateH2-Pharma, LLCNDACurrent
61269-410ETOPOPHOSetoposide phosphateH2-Pharma, LLCNDACurrent
61269-410ETOPOPHOSetoposide phosphateH2-Pharma, LLCNDACurrent
61269-410ETOPOPHOSetoposide phosphateH2-Pharma, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58557SUPPL2019-05-03
58545SUPPL2019-05-03
48539SUPPL2017-05-25
45898SUPPL2016-11-16
45894SUPPL2016-11-15
34676SUPPL2015-08-04
2564SUPPL2015-07-31
24997SUPPL2011-03-21
12607SUPPL2011-03-21
24996SUPPL2002-11-05
24995SUPPL2002-02-21
24994SUPPL2002-02-21