Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050587
Company: MERCK
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SODIUM; IMIPENEM | EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER;INTRAVENOUS | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|
| 01/30/2022 | SUPPL-83 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050587Orig1s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050587Orig1s083ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 01/30/2022 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050587Orig1s083lbl.pdf | |
| 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 |
| IMIPENEM AND CILASTATIN | CILASTATIN SODIUM; IMIPENEM | EQ 500MG BASE/VIAL;500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 207594 | HQ SPCLT PHARMA |
| PRIMAXIN | CILASTATIN SODIUM; IMIPENEM | EQ 500MG BASE/VIAL;500MG/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 050587 | MERCK |