FDA.reportPublic FDA data

Application 076806

Type
ANDA
Sponsor
DR REDDYS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEFEROXAMINE MESYLATEDEFEROXAMINE MESYLATEINJECTABLE;INJECTION500MG/VIALNoNo
002DEFEROXAMINE MESYLATEDEFEROXAMINE MESYLATEINJECTABLE;INJECTION2GM/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A076806-001DEFEROXAMINE MESYLATEDEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTION2006-03-31
A076806-002DEFEROXAMINE MESYLATEDEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTION2006-03-31

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A076806-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTION2006-03-31f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A076806-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTION2006-03-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076806-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTION2006-03-31e64feba35796…
2022-09-29 23:25 UTC2022-09A076806-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTION2006-03-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076806-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTION2006-03-31cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076806-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTION2006-03-31cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A076806-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTION2006-03-31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A076806-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTION2006-03-31a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DeferoxamineDEFEROXAMINE MESYLATEFresenius Kabi USA, LLCd91e16df-8daa-4cd2-86a2-273eaa2446e02026-06-15Warnings, Adverse reactionsName fallback
generic name: DEFEROXAMINE MESYLATE
Deferoxamine mesylateDEFEROXAMINE MESYLATEApotex Corp.c99553fb-3fae-b88a-6c2c-efa7520197f92026-05-29Warnings, Adverse reactionsName fallback
brand name: Deferoxamine mesylate
generic name: DEFEROXAMINE MESYLATE
Deferoxamine MesylateDEFEROXAMINE MESYLATEHospira, Inc.f9ab6b1c-98d0-4373-0e9b-b10cb4a675432026-04-06Warnings, Adverse reactionsName fallback
brand name: Deferoxamine Mesylate
generic name: DEFEROXAMINE MESYLATE
Deferoxamine mesylateDEFEROXAMINE MESYLATEGland Pharma Limited598fba68-f46e-4b6e-894c-63c2940b20632026-03-06Warnings, Adverse reactionsName fallback
brand name: Deferoxamine mesylate
generic name: DEFEROXAMINE MESYLATE
DesferalDEFEROXAMINE MESYLATEMITEM PHARMA38eff751-96c5-c48a-e063-6294a90a0e482025-07-02Name fallback
generic name: DEFEROXAMINE MESYLATE
DesferalDEFEROXAMINE MESYLATENovartis Pharmaceuticals Corporationa7174843-5965-49fc-b842-f7eff7b48bbc2025-06-17Warnings, Adverse reactionsName fallback
generic name: DEFEROXAMINE MESYLATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.