Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050706
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 205835 AUROBINDO PHARMA LTD
MEROPENEM MEROPENEM 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 204854 DAEWOONG PHARM CO
MEROPENEM MEROPENEM 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 206141 GLAND PHARMA LTD
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 205835 AUROBINDO PHARMA LTD
MEROPENEM MEROPENEM 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 204854 DAEWOONG PHARM CO
MEROPENEM MEROPENEM 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 206141 GLAND PHARMA LTD
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

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