FDA.reportPublic FDA data

Application 065275

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDEINJECTABLE;INJECTION1MG/MLNoNo
002IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDESOLUTION;INTRAVENOUS10MG/10ML (1MG/ML)NoNo
003IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDESOLUTION;INTRAVENOUS20MG/20ML (1MG/ML)NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065275-001IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDE5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUSAP2006-12-14
A065275-002IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2006-12-14
A065275-003IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDE20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAP2006-12-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A065275-001AP
A065275-002AP
A065275-003AP

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 22:54:322026-06A065275-001IDARUBICIN HYDROCHLORIDE5MG/5ML (1MG/ML)SOLUTION / INTRAVENOUSAP2006-12-14a50c72e98297…
2026-08-01 22:54:322026-06A065275-002IDARUBICIN HYDROCHLORIDE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2006-12-14a50c72e98297…
2026-08-01 22:54:322026-06A065275-003IDARUBICIN HYDROCHLORIDE20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAP2006-12-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065275-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A065275-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A065275-003AP1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Idarubicin HydrochlorideIDARUBICIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.7c20b574-285b-49eb-a98e-6752e4bb481d2025-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065275
application number: ANDA065275
ndc (product): 0143-9307
ndc (product): 0143-9308
ndc (product): 0143-9306
Idarubicin HydrochlorideIDARUBICIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.b9b337d5-50f7-4ea9-9df4-72c86e4c0b912023-04-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065275
application number: ANDA065275
ndc (product): 0143-9219
ndc (product): 0143-9218
ndc (product): 0143-9217

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9217Idarubicin HydrochlorideIdarubicin HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9217Idarubicin HydrochlorideIdarubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9218Idarubicin HydrochlorideIdarubicin HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9218Idarubicin HydrochlorideIdarubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9219Idarubicin HydrochlorideIdarubicin HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9219Idarubicin HydrochlorideIdarubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9306Idarubicin HydrochlorideIdarubicin HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9306Idarubicin HydrochlorideIdarubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9307Idarubicin HydrochlorideIdarubicin HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9307Idarubicin HydrochlorideIdarubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9308Idarubicin HydrochlorideIdarubicin HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9308Idarubicin HydrochlorideIdarubicin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent