Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088432
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE MEPERIDINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION 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
08/16/1984 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
12/16/2016 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

07/22/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/16/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/16/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/30/1992 SUPPL-7 Labeling

Label is not available on this site.

03/06/1992 SUPPL-3 Labeling

Label is not available on this site.

08/28/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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