FDA.reportPublic FDA data

Application 019661

Type
NDA
Sponsor
CHEPLAPHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYTOVENEGANCICLOVIR SODIUMINJECTABLE;INJECTIONEQ 500MG 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
N019661-001CYTOVENEGANCICLOVIR SODIUMEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-06-23

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 UTC2022-10N019661-001CYTOVENEEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-06-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019661-001CYTOVENEEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-06-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019661-001CYTOVENEEQ 500MG BASE/VIALINJECTABLE / INJECTIONRLD1989-06-23cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019661-001CYTOVENEEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-06-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N019661-001AP174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019661-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N019661-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019661-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019661-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019661-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N019661-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N019661-001AP1ea99ee380514…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GanciclovirGANCICLOVIR SODIUMFresenius Kabi USA, LLCb47f5d1c-36b8-49b6-a410-3b3f4661dde72026-01-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GANCICLOVIR SODIUM
GanciclovirGANCICLOVIR SODIUMFresenius Kabi USA, LLC35addab5-09db-4f8a-9c69-6fbce33ecc372026-01-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GANCICLOVIR SODIUM
GanciclovirGANCICLOVIR SODIUMHikma Pharmaceuticals USA Inc.4f8219ca-6780-4131-8962-9c3fdd0a84dd2025-02-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GANCICLOVIR SODIUM
ganciclovirGANCICLOVIR SODIUMSlate Run Pharmaceuticals, LLCeb100366-2a64-4742-af11-6177a8a494c82025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GANCICLOVIR SODIUM
ganciclovir sodiumGANCICLOVIR SODIUMSlate Run Pharmaceuticals, LLCcd293b9d-b573-4656-8574-19d7db870a9b2025-01-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GANCICLOVIR SODIUM
GanciclovirGANCICLOVIR SODIUMPharmascience Inc.3059c2da-d4a7-4aea-828c-20e671cb875c2022-12-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GANCICLOVIR SODIUM
ganciclovirGANCICLOVIR SODIUMSagent Pharmaceuticals993151ed-cea7-49a7-a967-fac3e9b3c85f2020-11-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GANCICLOVIR SODIUM

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0004-6940Cytoveneganciclovir sodiumGenentech, Inc.NDACurrent
0004-6940Cytoveneganciclovir sodiumGenentech, Inc.NDACurrent
61269-450Cytoveneganciclovir sodiumH2-Pharma, LLCNDACurrent
61269-450Cytoveneganciclovir sodiumH2-Pharma, LLCNDACurrent
61269-450Cytoveneganciclovir sodiumH2-Pharma, LLCNDACurrent
61269-450Cytoveneganciclovir sodiumH2-Pharma, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69818SUPPL2022-01-06
63155SUPPL2020-05-20
55122SUPPL2018-08-07
48909SUPPL2017-07-05
48908SUPPL2017-07-05
17533SUPPL2006-02-02
11611SUPPL2006-02-02