FDA.reportPublic FDA data

Application 022453

Type
NDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOPOTECAN HYDROCHLORIDETOPOTECAN HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 4MG BASE/4ML (EQ 1MG BASE/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N022453-001TOPOTECAN HYDROCHLORIDETOPOTECAN HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUS2012-12-20

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N022453-001TOPOTECAN HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUS2012-12-20a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topotecan HydrochlorideTOPOTECAN HYDROCHLORIDEFresenius Kabi USA, LLCb6019088-cd94-43b4-b5ce-ba20b6b8021e2026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Topotecan Hydrochloride
generic name: TOPOTECAN HYDROCHLORIDE
topotecan hydrochlorideTOPOTECAN HYDROCHLORIDEAccord Healthcare, Inc.729b2b22-1344-44f3-b614-14f6ec3c263e2024-10-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: topotecan hydrochloride
generic name: TOPOTECAN HYDROCHLORIDE
Topotecan hydrochlorideTOPOTECAN HYDROCHLORIDEActavis Pharma, Inc.996430c0-ee26-4ed9-82b8-a8b645becba62022-08-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Topotecan hydrochloride
generic name: TOPOTECAN HYDROCHLORIDE
HYCAMTINTOPOTECAN HYDROCHLORIDENovartis Pharmaceuticals Corporationeeee060c-a9ec-423e-a374-8484009f85242022-07-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOPOTECAN HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0703-4714TopotecanTopotecanTeva Parenteral Medicines, Inc.NDACurrent
0703-4714TopotecanTopotecanTeva Parenteral Medicines, Inc.NDACurrent
25021-236topotecantopotecanSagent PharmaceuticalsNDACurrent
25021-236topotecantopotecanSagent PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59181SUPPL2019-06-27
59166SUPPL2019-06-25
49838SUPPL2017-09-22
49817SUPPL2017-09-21
17596SUPPL2016-02-25
29737SUPPL2016-01-29
7406SUPPL2014-03-05
38720SUPPL2014-03-04
44755ORIG2013-07-26
22023ORIG2013-07-26
7405ORIG2012-12-26
38719ORIG2012-12-21