Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 201739
Company: KALEO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AUVI-Q EPINEPHRINE EQ 0.3MG/DELIVERY INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS Prescription BX Yes No
AUVI-Q EPINEPHRINE EQ 0.15MG/DELIVERY INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS Prescription BX 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
08/10/2012 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201739s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201739Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201739_auviQ_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/17/2017 SUPPL-9 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201739s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201739Orig1s008,s009ltr.pdf
11/17/2017 SUPPL-8 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201739s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201739Orig1s008,s009ltr.pdf
12/19/2016 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/17/2017 SUPPL-6 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201739Orig1s006ltr.pdf
05/18/2016 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201739s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201739Orig1s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/201739Orig1s004pkg.pdf
04/22/2015 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/22/2014 SUPPL-2 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
11/17/2017 SUPPL-9 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201739s008s009lbl.pdf
11/17/2017 SUPPL-8 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201739s008s009lbl.pdf
05/18/2016 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201739s004lbl.pdf
08/10/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201739s000lbl.pdf

AUVI-Q

There are no Therapeutic Equivalents.

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