Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090825
Company: HOSPIRA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMIPENEM AND CILASTATIN CILASTATIN SODIUM; IMIPENEM EQ 250MG BASE/VIAL;250MG/VIAL POWDER;INTRAVENOUS Prescription AP No No
IMIPENEM AND CILASTATIN CILASTATIN SODIUM; IMIPENEM EQ 500MG BASE/VIAL;500MG/VIAL POWDER;INTRAVENOUS Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/16/2011 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090825s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/17/2019 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

05/17/2019 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

06/12/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

06/12/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

05/23/2013 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

IMIPENEM AND CILASTATIN

POWDER;INTRAVENOUS; EQ 250MG BASE/VIAL;250MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMIPENEM AND CILASTATIN CILASTATIN SODIUM; IMIPENEM EQ 250MG BASE/VIAL;250MG/VIAL POWDER;INTRAVENOUS Prescription No AP 090825 HOSPIRA INC

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