Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 201739
Company: KALEO INC
Company: KALEO INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AUVI-Q | EPINEPHRINE | EQ 0.3MG/DELIVERY | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Prescription | BX | Yes | No |
AUVI-Q | EPINEPHRINE | EQ 0.15MG/DELIVERY | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Prescription | BX | Yes | Yes |
AUVI-Q | EPINEPHRINE | EQ 0.1MG/DELIVERY | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Prescription | None | Yes | No |
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 |
---|---|---|---|---|---|
02/28/2024 | SUPPL-28 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201739s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/201739Orig1s028ltr.pdf | |
09/28/2019 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201739s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201739Orig1s015ltr.pdf | |
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 |
---|---|---|---|---|---|
02/28/2024 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201739s028lbl.pdf | |
02/28/2024 | SUPPL-28 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201739s028lbl.pdf | |
02/28/2024 | SUPPL-28 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201739s028lbl.pdf | |
09/28/2019 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201739s015lbl.pdf | |
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.