Drugs@FDA: FDA-Approved Drugs
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 |