FDA.reportPublic FDA data

Application 091007

Type
ANDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMIPENEM AND CILASTATINCILASTATIN SODIUM; IMIPENEMPOWDER;INTRAVENOUSEQ 500MG BASE/VIAL;500MG/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091007-001IMIPENEM 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.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A091007-001IMIPENEM AND CILASTATINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUS2011-11-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091007-001IMIPENEM AND CILASTATINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUS2011-11-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A091007-001IMIPENEM AND CILASTATINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUS2011-11-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A091007-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091007-001AP1ea99ee380514…

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 · 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

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9310ORIG2011-11-21