Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090577
Company: ACS DOBFAR
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 None No Yes
IMIPENEM AND CILASTATIN CILASTATIN SODIUM; IMIPENEM EQ 500MG BASE/VIAL;500MG/VIAL POWDER;INTRAVENOUS Prescription AP 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
12/21/2011 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/09/2019 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

07/09/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

05/29/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

05/29/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

04/15/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

IMIPENEM AND CILASTATIN

POWDER;INTRAVENOUS; EQ 500MG BASE/VIAL;500MG/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 500MG BASE/VIAL;500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 090577 ACS DOBFAR
IMIPENEM AND CILASTATIN CILASTATIN SODIUM; IMIPENEM EQ 500MG BASE/VIAL;500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 090825 HOSPIRA INC
IMIPENEM AND CILASTATIN CILASTATIN SODIUM; IMIPENEM EQ 500MG BASE/VIAL;500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 091007 HOSPIRA INC
PRIMAXIN CILASTATIN SODIUM; IMIPENEM EQ 500MG BASE/VIAL;500MG/VIAL POWDER;INTRAVENOUS Prescription Yes AP 050587 MERCK

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