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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200327
Company: ABBVIE

Summary Review

Products on NDA 200327

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TEFLARO	CEFTAROLINE FOSAMIL	400MG/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes
TEFLARO	CEFTAROLINE FOSAMIL	600MG/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200327

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/2010	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200327s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200327s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200327Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200327Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/02/2021	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200327Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/200327Orig1s028ltr.pdf
11/27/2020	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200327s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/200327Orig1s025ltr.pdf
09/13/2019	SUPPL-22	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200327s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/200327Orig1s022ltr.pdf
05/27/2016	SUPPL-17	Efficacy-New Patient Population	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/2016/200327s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200327Orig1s016,s017ltr.pdf
05/27/2016	SUPPL-16	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200327s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200327Orig1s016,s017ltr.pdf
08/31/2015	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200327s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200327Orig1s013,200327Orig1s014,200327Orig1s015ltr.pdf
08/31/2015	SUPPL-14	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200327s013s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200327Orig1s013,200327Orig1s014,200327Orig1s015ltr.pdf
08/31/2015	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200327Orig1s013,200327Orig1s014,200327Orig1s015ltr.pdf
02/28/2014	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
12/16/2013	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200327s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200327Orig1s011ltr.pdf
07/29/2013	SUPPL-10	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200327Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200327Orig1s010ltr.pdf
05/29/2013	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200327s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200327Orig1s009ltr.pdf
10/23/2012	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200327s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200327Orig1s008ltr.pdf
05/03/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200327s007lbl.pdf
05/22/2012	SUPPL-5	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200327s005ltr.pdf
03/11/2011	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200327s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200327s003ltr.pdf
06/29/2011	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200327s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200327s001ltr.pdf

Labels for NDA 200327

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/02/2021	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200327Orig1s028lbl.pdf
11/27/2020	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200327s025lbl.pdf
09/13/2019	SUPPL-22	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200327s022lbl.pdf
05/27/2016	SUPPL-17	Efficacy-New Patient Population	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/2016/200327s016s017lbl.pdf
05/27/2016	SUPPL-16	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200327s016s017lbl.pdf
08/31/2015	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200327s015lbl.pdf
08/31/2015	SUPPL-14	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200327s013s014s015lbl.pdf
12/16/2013	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200327s011lbl.pdf
07/29/2013	SUPPL-10	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200327Orig1s010lbl.pdf
05/29/2013	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200327s009lbl.pdf
10/23/2012	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200327s008lbl.pdf
05/03/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200327s007lbl.pdf
06/29/2011	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200327s001lbl.pdf
03/11/2011	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200327s003lbl.pdf
10/29/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200327s000lbl.pdf

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