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 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 |