Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050587
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 POWDER;INTRAVENOUS Discontinued None Yes No
PRIMAXIN CILASTATIN SODIUM; IMIPENEM EQ 500MG BASE/VIAL;500MG/VIAL POWDER;INTRAVENOUS Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/26/1985 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050587Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/12/2018 SUPPL-81 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050587s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050587Orig1s081ltr.pdf
08/06/2018 SUPPL-80 Labeling-Package Insert

Label is not available on this site.

03/11/2016 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

02/19/2016 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

12/16/2014 SUPPL-76 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050587s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050587Orig1s076ltr.pdf
08/26/2014 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

12/16/2016 SUPPL-74 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050587s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050587Orig1s074ltr.pdf
04/16/2012 SUPPL-73 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050587s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050587s073ltr.pdf
08/26/2009 SUPPL-72 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-70 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-65 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
08/04/2006 SUPPL-64 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-61 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/2004/050587_S061_PRIMAXIN.pdf
07/09/2002 SUPPL-59 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050587_S059_PRIMAXIN.pdf
03/04/2003 SUPPL-58 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/2003/050587_S058_PRIMAXIN.pdf
05/28/2002 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

08/29/2001 SUPPL-55 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050587_S055_PRIMAXIN I.V.pdf
07/23/2001 SUPPL-54 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050587_S054_PRIMAXIN I.V..pdf
11/30/2001 SUPPL-53 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50587s53ltr.pdf
08/28/2000 SUPPL-52 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/050587_S052_PRIMAXIN I.V..pdf
07/13/1999 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

02/04/1999 SUPPL-50 Labeling

Label is not available on this site.

07/24/1998 SUPPL-49 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/08/1998 SUPPL-48 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/50587s5-lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50587sltr.pdf
06/30/1997 SUPPL-47 Labeling

Label is not available on this site.

09/19/1996 SUPPL-46 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050587_S046_PRIMAXIN.pdf
01/09/1997 SUPPL-45 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050587_S045_PRIMAXIN.pdf
03/10/1995 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

09/27/1994 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

03/21/1995 SUPPL-41 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050587_S041_PRIMAXIN.pdf
11/19/1993 SUPPL-40 Labeling

Label is not available on this site.

09/12/1996 SUPPL-39 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050587_S039_PRIMAXIN.pdf
06/24/1994 SUPPL-38 Labeling

Label is not available on this site.

07/17/1992 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/23/1992 SUPPL-36 Labeling

Label is not available on this site.

01/14/1992 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

11/04/1993 SUPPL-33 Labeling

Label is not available on this site.

08/26/1991 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1994 SUPPL-26 Labeling

Label is not available on this site.

08/24/1990 SUPPL-25 Labeling

Label is not available on this site.

03/30/1989 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

12/12/1988 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1988 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1988 SUPPL-20 Labeling

Label is not available on this site.

01/11/1988 SUPPL-18 Labeling

Label is not available on this site.

01/25/1988 SUPPL-17 Labeling

Label is not available on this site.

10/08/1987 SUPPL-13 Labeling

Label is not available on this site.

10/29/1986 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/08/1987 SUPPL-4 Labeling

Label is not available on this site.

10/08/1987 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/12/2018 SUPPL-81 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050587s081lbl.pdf
12/16/2016 SUPPL-74 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050587s074lbl.pdf
12/16/2014 SUPPL-76 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050587s076lbl.pdf
04/16/2012 SUPPL-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050587s073lbl.pdf
08/26/2009 SUPPL-72 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050587s072,050630s035lbl.pdf
03/28/2008 SUPPL-65 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050587s065,050630s028lbl.pdf
04/08/1998 SUPPL-48 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/50587s5-lbl.pdf

PRIMAXIN

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
PRIMAXIN CILASTATIN SODIUM; IMIPENEM EQ 500MG BASE/VIAL;500MG/VIAL POWDER;INTRAVENOUS Prescription Yes AP 050587 MERCK

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English