Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062756
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRIMAXIN CILASTATIN SODIUM; IMIPENEM EQ 250MG BASE/VIAL;250MG/VIAL INJECTABLE;INJECTION Discontinued None No No
PRIMAXIN CILASTATIN SODIUM; IMIPENEM EQ 500MG BASE/VIAL;500MG/VIAL 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
01/08/1987 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
03/17/2017 SUPPL-58 Labeling-Package Insert

Label is not available on this site.

04/02/2017 SUPPL-56 Labeling-Package Insert

Label is not available on this site.

06/28/2013 SUPPL-55 Labeling-Package Insert

Label is not available on this site.

02/28/2011 SUPPL-53 Labeling-Container/Carton Labels

Label is not available on this site.

05/08/2012 SUPPL-51 Labeling

Label is not available on this site.

04/23/2010 SUPPL-46 Labeling

Label is not available on this site.

09/19/2006 SUPPL-45 Labeling

Label is not available on this site.

04/16/2004 SUPPL-41 Labeling

Label is not available on this site.

04/16/2004 SUPPL-39 Labeling

Label is not available on this site.

10/17/2002 SUPPL-38 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/062756_S038_PRIMAXIN_ADD_VANTAGE.pdf
08/20/2002 SUPPL-37 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/062756_S037_PRIMAXIN_ADD_VANTAGE.pdf
04/19/2002 SUPPL-35 Manufacturing (CMC)-Facility Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/062756_S035_PRIMAXIN_ADD_VANTAGE.pdf
10/11/2001 SUPPL-34 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/062756_S033&S034_PRIMAXIN_VANTAGE.pdf
10/11/2001 SUPPL-33 Manufacturing (CMC)-Facility Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/062756_S033&S034_PRIMAXIN_VANTAGE.pdf
09/10/2001 SUPPL-32 Manufacturing (CMC)-Manufacturing Process Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/062756_S032_PRIMAXIN_I.V._VANTAGE.pdf
08/31/2001 SUPPL-31 Labeling

Label is not available on this site.

11/29/1999 SUPPL-30 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/062756_S030_PRIMAXIN.pdf
01/28/1999 SUPPL-29 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/062756_S029_PRIMAXIN.pdf
03/17/1998 SUPPL-28 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/062756_S028_PRIMAXIN.pdf
10/31/1996 SUPPL-27 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/062756_S027_PRIMAXIN I.V.pdf
10/11/1996 SUPPL-26 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/062756_S018&S022&S026_PRIMAXIN I.V.pdf
05/08/1996 SUPPL-25 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/062756_S025_PRIMAXIN I.V.pdf
08/31/2001 SUPPL-24 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/062756_S024_PRIMAXIN_ADD_VANTAGE.pdf
04/30/1997 SUPPL-23 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/062756_S023_PRIMAXIN.pdf
10/11/1996 SUPPL-22 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/062756_S018&S022&S026_PRIMAXIN I.V.pdf
05/09/1995 SUPPL-21 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S021_PRIMAXIN ADD-VANTAGE.pdf
09/02/1994 SUPPL-20 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S020_PRIMAXIN ADD-VANTAGE.pdf
07/12/1995 SUPPL-19 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S011&S017&S019_PRIMAXIN
10/11/1996 SUPPL-18 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/062756_S018&S022&S026_PRIMAXIN I.V.pdf
07/12/1995 SUPPL-17 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S011&S017&S019_PRIMAXIN
08/31/1992 SUPPL-15 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S015_PRIMAXIN ADD-VANTAGE.pdf
02/03/1993 SUPPL-14 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S014_PRIMAXIN ADD-VANTAGE.pdf
02/18/1992 SUPPL-13 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S013_PRIMAXIN ADD-VANTAGE.pdf
02/18/1992 SUPPL-12 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S012_PRIMAXIN ADD-VANTAGE.pdf
07/12/1995 SUPPL-11 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S011&S017&S019_PRIMAXIN
12/29/1993 SUPPL-10 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S005&S007&S008&S010_PRIMAXIN I.V.pdf
09/09/1991 SUPPL-9 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S009_PRIMAXIN_ADD_VANTAGE.pdf
12/29/1993 SUPPL-8 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S005&S007&S008&S010_PRIMAXIN I.V.pdf
12/29/1993 SUPPL-7 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S005&S007&S008&S010_PRIMAXIN I.V.pdf
09/09/1991 SUPPL-6 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S006_ADD_PRIMAXIN_VANTAGE.pdf
12/29/1993 SUPPL-5 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S005&S007&S008&S010_PRIMAXIN I.V.pdf
02/26/1991 SUPPL-4 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S004_PRIMAXIN_ADD_VANTAGE.pdf
03/07/1991 SUPPL-3 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062756_S003_PRIMAXIN_ADD_VANTAGE.pdf

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