FDA.reportPublic FDA data

Application 207321

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXRAZOXANE HYDROCHLORIDEDEXRAZOXANE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo
002DEXRAZOXANE HYDROCHLORIDEDEXRAZOXANE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 250MG BASE/VIALNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207321-001DEXRAZOXANE HYDROCHLORIDEDEXRAZOXANE HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2016-11-28
A207321-002DEXRAZOXANE HYDROCHLORIDEDEXRAZOXANE HYDROCHLORIDEEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2019-12-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A207321-001AP
A207321-002AP

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 22:54:322026-06A207321-001DEXRAZOXANE HYDROCHLORIDEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2016-11-28a50c72e98297…
2026-08-01 22:54:322026-06A207321-002DEXRAZOXANE HYDROCHLORIDEEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2019-12-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207321-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A207321-002AP1a50c72e98297…

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
DexrazoxaneDEXRAZOXANE FOR INJECTIONAlmaject, Inc.9cbd2987-10bb-eceb-153d-ee7be1ed0c842025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207321
application number: ANDA207321
ndc (product): 72611-716
DexrazoxaneDEXRAZOXANE FOR INJECTIONAlmaject, Inc.e9550d22-6069-a6de-9968-6a18c9e0448f2025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207321
application number: ANDA207321
ndc (product): 72611-716
DexrazoxaneDEXRAZOXANE FOR INJECTIONGland Pharma Limitedc9c625fc-8852-4ed4-bcf2-63f46a7067822025-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207321
application number: ANDA207321
ndc (product): 68083-195
DexrazoxaneDEXRAZOXANE FOR INJECTIONFosun Pharma USA Inc.c1d98fbe-5fd9-4518-b1a5-fac92e32928f2025-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207321
application number: ANDA207321
ndc (product): 72266-235
ndc (product): 72266-101

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-578DexrazoxaneDexrazoxane for InjectionAlvogen Inc.ANDACurrent
47781-578DexrazoxaneDexrazoxane for InjectionAlvogen Inc.ANDACurrent
47781-578DexrazoxaneDexrazoxane for InjectionAlvogen Inc.ANDACurrent
51991-942DexrazoxaneDexrazoxane HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-942DexrazoxaneDexrazoxane HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
68083-195DexrazoxaneDexrazoxane for InjectionGland Pharma LimitedANDACurrent
72266-101DexrazoxaneDexrazoxane for InjectionFosun Pharma USA Inc.ANDACurrent
72266-101DexrazoxaneDexrazoxane for InjectionFosun Pharma USA Inc.ANDACurrent
72266-101DexrazoxaneDexrazoxane for InjectionFosun Pharma USA Inc.ANDACurrent
72266-101DexrazoxaneDexrazoxane for InjectionFosun Pharma USA Inc.ANDACurrent
72266-235DexrazoxaneDexrazoxane for InjectionFosun Pharma USA Inc.ANDACurrent
72266-235DexrazoxaneDexrazoxane for InjectionFosun Pharma USA Inc.ANDACurrent
72611-716DexrazoxaneDexrazoxane for InjectionAlmaject, Inc.ANDACurrent
72611-716DexrazoxaneDexrazoxane for InjectionAlmaject, Inc.ANDACurrent
72611-716DexrazoxaneDexrazoxane for InjectionAlmaject, Inc.ANDACurrent
72611-716DexrazoxaneDexrazoxane for InjectionAlmaject, Inc.ANDACurrent