FDA.reportPublic FDA data

Application 202268

Type
ANDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
002CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDEINJECTABLE;INJECTIONEQ 2GM 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
A202268-001CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTION2012-07-30
A202268-002CEFEPIME HYDROCHLORIDECEFEPIME HYDROCHLORIDEEQ 2GM BASE/VIALINJECTABLE / INJECTION2012-07-30

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 22:54:322026-06A202268-001CEFEPIME HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTION2012-07-30a50c72e98297…
2026-08-01 22:54:322026-06A202268-002CEFEPIME HYDROCHLORIDEEQ 2GM BASE/VIALINJECTABLE / INJECTION2012-07-30a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CEFEPIME HYDROCHLORIDE AND DEXTROSECEFEPIME HYDROCHLORIDEB. Braun Medical Inc.57517a0e-ec1b-4605-a7cc-7e3801158ec92026-04-07Warnings, Adverse reactionsName fallback
generic name: CEFEPIME HYDROCHLORIDE
Cefepime HydrochlorideCEFEPIME HYDROCHLORIDEHikma Pharmaceuticals USA Inc.b9914e7e-13f6-42d4-9cbb-8c7ed1ce7a012025-10-14Warnings, Adverse reactionsName fallback
brand name: Cefepime Hydrochloride
generic name: CEFEPIME HYDROCHLORIDE
Cefepime HydrochlorideCEFEPIME HYDROCHLORIDEHikma Pharmaceuticals USA Inc.f64c181e-28c5-48ab-aa67-5ca0e3fd079c2025-06-30Warnings, Adverse reactionsName fallback
brand name: Cefepime Hydrochloride
generic name: CEFEPIME HYDROCHLORIDE
CefepimeCEFEPIME HYDROCHLORIDEQilu Pharmaceutical Co., Ltd.80b4c811-4a71-47fb-8565-85ce9d0f782c2021-11-15Warnings, Adverse reactionsName fallback
generic name: CEFEPIME HYDROCHLORIDE
cefepimeCEFEPIME HYDROCHLORIDESagent Pharmaceuticalsde477f37-40f6-4295-ae72-a2ee36a8922e2021-09-29Warnings, Adverse reactionsName fallback
generic name: CEFEPIME HYDROCHLORIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22881ORIG2012-10-09