Application 063221

Type
ANDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFTAZIDIME SODIUM IN PLASTIC CONTAINERCEFTAZIDIME SODIUMINJECTABLE;INJECTIONEQ 10MG BASE/MLNoNo
002CEFTAZIDIME SODIUM IN PLASTIC CONTAINERCEFTAZIDIME SODIUMINJECTABLE;INJECTIONEQ 20MG BASE/MLNoNo
003CEFTAZIDIME SODIUM IN PLASTIC CONTAINERCEFTAZIDIME SODIUMINJECTABLE;INJECTIONEQ 40MG BASE/MLNoNo

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

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
A063221-001CEFTAZIDIME SODIUM IN PLASTIC CONTAINERCEFTAZIDIME SODIUMEQ 10MG BASE/MLINJECTABLE / INJECTION1993-04-29
A063221-002CEFTAZIDIME SODIUM IN PLASTIC CONTAINERCEFTAZIDIME SODIUMEQ 20MG BASE/MLINJECTABLE / INJECTION1993-04-29
A063221-003CEFTAZIDIME SODIUM IN PLASTIC CONTAINERCEFTAZIDIME SODIUMEQ 40MG BASE/MLINJECTABLE / INJECTION1993-04-29

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A063221-001CEFTAZIDIME SODIUM IN PLASTIC CONTAINEREQ 10MG BASE/MLINJECTABLE / INJECTION1993-04-29f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A063221-002CEFTAZIDIME SODIUM IN PLASTIC CONTAINEREQ 20MG BASE/MLINJECTABLE / INJECTION1993-04-29f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A063221-003CEFTAZIDIME SODIUM IN PLASTIC CONTAINEREQ 40MG BASE/MLINJECTABLE / INJECTION1993-04-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A063221-001CEFTAZIDIME SODIUM IN PLASTIC CONTAINEREQ 10MG BASE/MLINJECTABLE / INJECTION1993-04-29e64feba35796…
2022-09-29 23:25 UTC2022-09A063221-002CEFTAZIDIME SODIUM IN PLASTIC CONTAINEREQ 20MG BASE/MLINJECTABLE / INJECTION1993-04-29e64feba35796…
2022-09-29 23:25 UTC2022-09A063221-003CEFTAZIDIME SODIUM IN PLASTIC CONTAINEREQ 40MG BASE/MLINJECTABLE / INJECTION1993-04-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A063221-001CEFTAZIDIME SODIUM IN PLASTIC CONTAINEREQ 10MG BASE/MLINJECTABLE / INJECTION1993-04-29cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A063221-002CEFTAZIDIME SODIUM IN PLASTIC CONTAINEREQ 20MG BASE/MLINJECTABLE / INJECTION1993-04-29cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A063221-003CEFTAZIDIME SODIUM IN PLASTIC CONTAINEREQ 40MG BASE/MLINJECTABLE / INJECTION1993-04-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A063221-001CEFTAZIDIME SODIUM IN PLASTIC CONTAINEREQ 10MG BASE/MLINJECTABLE / INJECTION1993-04-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A063221-002CEFTAZIDIME SODIUM IN PLASTIC CONTAINEREQ 20MG BASE/MLINJECTABLE / INJECTION1993-04-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A063221-003CEFTAZIDIME SODIUM IN PLASTIC CONTAINEREQ 40MG BASE/MLINJECTABLE / INJECTION1993-04-29a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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