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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050706
Company: PFIZER

Products on NDA 50706

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

Labels for NDA 050706

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

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