FDA.reportPublic FDA data

Application 065197

Type
ANDA
Sponsor
WOCKHARDT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFOTAXIMECEFOTAXIME SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
002CEFOTAXIME SODIUMCEFOTAXIME SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo
003CEFOTAXIME SODIUMCEFOTAXIME SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALNoNo

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
A065197-001CEFOTAXIMECEFOTAXIME SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-29
A065197-002CEFOTAXIME SODIUMCEFOTAXIME SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2008-06-20
A065197-003CEFOTAXIME SODIUMCEFOTAXIME SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2008-06-20

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.

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 UTC2022-10A065197-001CEFOTAXIMEEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-29f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A065197-002CEFOTAXIME SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2008-06-20f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A065197-003CEFOTAXIME SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2008-06-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065197-001CEFOTAXIMEEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-29e64feba35796…
2022-09-29 23:25 UTC2022-09A065197-002CEFOTAXIME SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2008-06-20e64feba35796…
2022-09-29 23:25 UTC2022-09A065197-003CEFOTAXIME SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2008-06-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065197-001CEFOTAXIMEEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-29cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065197-002CEFOTAXIME SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2008-06-20cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065197-003CEFOTAXIME SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2008-06-20cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A065197-001CEFOTAXIMEEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A065197-002CEFOTAXIME SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2008-06-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A065197-003CEFOTAXIME SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2008-06-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A065197-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065197-002AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065197-003AP174a2ff9319b5…
2019-09-15 20:21 UTC2019-09A065197-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A065197-002AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A065197-003AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065197-001AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A065197-002AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A065197-003AP1ea99ee380514…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefotaximeCEFOTAXIME INJECTIONSteriMax Inc.8efe3bd0-c43a-2bd6-e053-2a95a90a92fa2026-06-15Name fallback
brand name: Cefotaxime
CefotaximeCEFOTAXIMEHikma Pharmaceuticals USA Inc.ed23b6bc-32c7-4c50-a53d-313ae78e56232024-04-11Warnings, Adverse reactionsName fallback
brand name: Cefotaxime
CefotaximeCEFOTAXIMEHikma Pharmaceuticals USA Inc.ef1a6dc6-bc3d-4f09-8f92-7ff328f565612024-04-11Warnings, Adverse reactionsName fallback
brand name: Cefotaxime

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55648-947CEFOTAXIMECEFOTAXIMEWOCKHARDT LIMITEDANDACurrent
55648-948CEFOTAXIMECEFOTAXIMEWOCKHARDT LIMITEDANDACurrent
55648-986CEFOTAXIMECEFOTAXIMEWOCKHARDT LIMITEDANDACurrent
64679-947CefotaximeCefotaximeWockhardt USA LLC.ANDACurrent
64679-947CefotaximeCefotaximeWockhardt USA LLC.ANDACurrent
64679-948CefotaximeCefotaximeWockhardt USA LLC.ANDACurrent
64679-948CefotaximeCefotaximeWockhardt USA LLC.ANDACurrent
64679-986CefotaximeCefotaximeWockhardt USA LLC.ANDACurrent
64679-986CefotaximeCefotaximeWockhardt USA LLC.ANDACurrent