Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050630
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRIMAXIN CILASTATIN SODIUM; IMIPENEM EQ 500MG BASE/VIAL;500MG/VIAL POWDER;INTRAMUSCULAR Discontinued None No No
PRIMAXIN CILASTATIN SODIUM; IMIPENEM EQ 750MG BASE/VIAL;750MG/VIAL POWDER;INTRAMUSCULAR 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
12/14/1990 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/26/2009 SUPPL-35 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050587s072,050630s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050587s072,050630s035ltr.pdf
05/08/2008 SUPPL-33 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050587s070, 050630s033ltr.pdf
03/28/2008 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050587s065,050630s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050587s065, 050630s028ltr.pdf
03/22/2007 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050630s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050630s027LTR.pdf
08/04/2006 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050587s064, 050630s026LTR.pdf
05/20/2004 SUPPL-23 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50630slr023,50587slr061ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050630_S023_PRIMAXIN.pdf
03/04/2003 SUPPL-21 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50587SLR058,50630SLR021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050630_S021_PRIMAXIN.pdf
05/28/2002 SUPPL-19 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050630_S019_PRIMAXIN.pdf
08/29/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/2001 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50587s53ltr.pdf
04/10/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

02/04/1999 SUPPL-15 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50638S15_Primaxin.pdf
06/30/1997 SUPPL-14 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050630_S014_PRIMAXIN.pdf
04/27/1995 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1997 SUPPL-11 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050630_S011_PRIMAXIN.pdf
09/27/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/02/1996 SUPPL-9 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050630_S009_PRIMAXIN.pdf
06/24/1994 SUPPL-8 Labeling

Label is not available on this site.

11/23/1992 SUPPL-7 Labeling

Label is not available on this site.

11/23/1992 SUPPL-6 Labeling

Label is not available on this site.

11/04/1993 SUPPL-5 Labeling

Label is not available on this site.

11/04/1993 SUPPL-2 Labeling

Label is not available on this site.

08/26/1991 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/26/2009 SUPPL-35 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050587s072,050630s035lbl.pdf
03/28/2008 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050587s065,050630s028lbl.pdf
03/22/2007 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050630s027lbl.pdf

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