FDA.reportPublic FDA data

Application 212001

Type
ANDA
Sponsor
CUSTOPHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GANCICLOVIR SODIUMGANCICLOVIR SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo

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
A212001-001GANCICLOVIR SODIUMGANCICLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2019-06-20

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 22:54:322026-06A212001-001GANCICLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2019-06-20a50c72e98297…

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 · 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
brand name: ganciclovir sodium
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

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24201-500GanciclovirGanciclovirLeucadia PharmaceuticalsANDACurrent