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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020457-001ETOPOPHOS PRESERVATIVE FREEETOPOSIDE PHOSPHATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS1996-05-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020457-001ETOPOPHOS PRESERVATIVE FREEEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS1996-05-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020457-001ETOPOPHOS PRESERVATIVE FREEEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS1996-05-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020457-001ETOPOPHOS PRESERVATIVE FREEEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS1996-05-17cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020457-001ETOPOPHOS PRESERVATIVE FREEEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS1996-05-17a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ETOPOPHOSETOPOSIDE PHOSPHATEH2-Pharma, LLC7499fc35-fae8-44ad-bbab-9a1a589bf3ee2026-07-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 020457
application number: NDA020457
ndc (product): 61269-410

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

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