Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 200327
Company: ABBVIE
Company: ABBVIE
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 |
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 |
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 |