Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 200327
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEFLARO CEFTAROLINE FOSAMIL 400MG/VIAL POWDER;INTRAVENOUS Prescription None Yes No
TEFLARO CEFTAROLINE FOSAMIL 600MG/VIAL POWDER;INTRAVENOUS Prescription None 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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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