FDA.reportPublic FDA data

Application 090825

Type
ANDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMIPENEM AND CILASTATINCILASTATIN SODIUM; IMIPENEMPOWDER;INTRAVENOUSEQ 250MG BASE/VIAL;250MG/VIALNoNo
002IMIPENEM AND CILASTATINCILASTATIN SODIUM; IMIPENEMPOWDER;INTRAVENOUSEQ 500MG BASE/VIAL;500MG/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
A090825-001IMIPENEM AND CILASTATINCILASTATIN SODIUM; IMIPENEMEQ 250MG BASE/VIAL;250MG/VIALPOWDER / INTRAVENOUS2011-11-16
A090825-002IMIPENEM AND CILASTATINCILASTATIN SODIUM; IMIPENEMEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUS2011-11-16

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 22:54:322026-06A090825-001IMIPENEM AND CILASTATINEQ 250MG BASE/VIAL;250MG/VIALPOWDER / INTRAVENOUS2011-11-16a50c72e98297…
2026-08-01 22:54:322026-06A090825-002IMIPENEM AND CILASTATINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUS2011-11-16a50c72e98297…

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
Imipenem and CilastatinIMIPENEM AND CILASTATINWG Critical Care, LLC46f54df9-5afe-430c-aa19-0d84c2044b0b2025-01-16Warnings, Adverse reactionsName fallback
brand name: Imipenem and Cilastatin
Imipenem and CilastatinIMIPENEM AND CILASTATIN SODIUMFresenius Kabi USA, LLCce771566-c4f2-447e-944a-6b908925c90b2022-10-11Warnings, Adverse reactionsName fallback
brand name: Imipenem and Cilastatin
Imipenem and CilastatinIMIPENEM AND CILASTATIN SODIUMFresenius Kabi USA, LLC0a1dd9b9-ada1-4bff-9dcb-18961254e9e82022-10-10Warnings, Adverse reactionsName fallback
brand name: Imipenem and Cilastatin
Imipenem and CilastatinIMIPENEM AND CILASTATIN SODIUMFresenius Kabi USA, LLC6ab0ca9e-9a79-4cab-9f09-470eda06952e2022-10-06Warnings, Adverse reactionsName fallback
brand name: Imipenem and Cilastatin

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-3507Imipenem and CilastatinImipenem and CilastatinHospira, Inc.ANDACurrent
0409-3508Imipenem and CilastatinImipenem and CilastatinHospira, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31501ORIG2011-11-21