Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050706
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MERREM | MEROPENEM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| MERREM | MEROPENEM | 500MG/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 06/21/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 04/27/2019 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050706s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050706Orig1s041ltr.pdf | |
| 06/05/2018 | SUPPL-40 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050706s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050706Orig1s040ltr.pdf | |
| 01/18/2018 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050706s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050706Orig1s039ltr.pdf | |
| 12/30/2016 | SUPPL-37 | 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/2016/050706s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050706Orig1s037ltr.pdf |
| 07/27/2016 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050706s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050706Orig1s036ltr.pdf | |
| 12/19/2014 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050706s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050706Orig1s035ltr.pdf | |
| 12/16/2013 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050706s032s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050706Orig1s032,s034ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/050706Orig1s034.pdf | |
| 06/18/2014 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/2013 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050706s032s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050706Orig1s032,s034ltr.pdf | |
| 03/28/2013 | SUPPL-31 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050706s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050706Orig1s031ltr.pdf | |
| 12/23/2010 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050706s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050706s028ltr.pdf | |
| 08/06/2009 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050706s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050706s025ltr.pdf | |
| 03/13/2008 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050706s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050706s023ltr.pdf | |
| 03/27/2008 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050706s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050706s022ltr.pdf | |
| 08/17/2005 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050706s020ltr.pdf |
| 05/25/2005 | SUPPL-18 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050706s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050706s018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/050706_S018_MERREM.pdf | |
| 06/04/2004 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50706slr016ltr.pdf |
| 06/05/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/18/2002 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/2001 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/2001 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/2001 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/31/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/23/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/12/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/27/2019 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050706s041lbl.pdf | |
| 06/05/2018 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050706s040lbl.pdf | |
| 06/05/2018 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050706s040lbl.pdf | |
| 01/18/2018 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050706s039lbl.pdf | |
| 12/30/2016 | SUPPL-37 | 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/2016/050706s037lbl.pdf |
| 07/27/2016 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050706s036lbl.pdf | |
| 12/19/2014 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050706s035lbl.pdf | |
| 12/16/2013 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050706s032s034lbl.pdf | |
| 12/16/2013 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050706s032s034lbl.pdf | |
| 03/28/2013 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050706s031lbl.pdf | |
| 03/28/2013 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050706s031lbl.pdf | |
| 12/23/2010 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050706s028lbl.pdf | |
| 08/06/2009 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050706s025lbl.pdf | |
| 03/27/2008 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050706s022lbl.pdf | |
| 03/13/2008 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050706s023lbl.pdf | |
| 05/25/2005 | SUPPL-18 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050706s018lbl.pdf |
MERREM
INJECTABLE;INJECTION; 1GM/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MEROPENEM | MEROPENEM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091404 | ACS DOBFAR |
| MEROPENEM | MEROPENEM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204139 | ACS DOBFAR SPA |
| MEROPENEM | MEROPENEM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205883 | AMNEAL PHARMS |
| MEROPENEM | MEROPENEM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216154 | BROOKS STERISCIENCE |
| MEROPENEM | MEROPENEM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204854 | DAEWOONG PHARM CO |
| MEROPENEM | MEROPENEM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205835 | EUGIA PHARMA |
| MEROPENEM | MEROPENEM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206141 | GLAND |
| MEROPENEM | MEROPENEM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 210773 | HQ SPCLT PHARMA |
| MEROPENEM | MEROPENEM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206086 | SAVIOR LIFETEC CORP |
| MERREM | MEROPENEM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050706 | PFIZER |
INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MEROPENEM | MEROPENEM | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091404 | ACS DOBFAR |
| MEROPENEM | MEROPENEM | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204139 | ACS DOBFAR SPA |
| MEROPENEM | MEROPENEM | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205883 | AMNEAL PHARMS |
| MEROPENEM | MEROPENEM | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216154 | BROOKS STERISCIENCE |
| MEROPENEM | MEROPENEM | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204854 | DAEWOONG PHARM CO |
| MEROPENEM | MEROPENEM | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205835 | EUGIA PHARMA |
| MEROPENEM | MEROPENEM | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206141 | GLAND |
| MEROPENEM | MEROPENEM | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 210773 | HQ SPCLT PHARMA |
| MEROPENEM | MEROPENEM | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206086 | SAVIOR LIFETEC CORP |
| MERREM | MEROPENEM | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050706 | PFIZER |