Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.3MG/DELIVERY | 1 | AUVI-Q | EPINEPHRINE |
| 002 | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.15MG/DELIVERY | 1 | AUVI-Q | EPINEPHRINE |
| 003 | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | EQ 0.1MG/DELIVERY | 1 | AUVI-Q | EPINEPHRINE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2012-08-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2014-03-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2015-04-22 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-05-18 | 901 REQUIRED |
| UNKNOWN; | SUPPL | 6 | AP | 2017-02-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2016-12-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2017-11-17 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 2017-11-17 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2019-09-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 15 | Null | 6 |
TE Codes
| 001 | Prescription | BX |
| 002 | Prescription | BX |
CDER Filings
KALEO INC
cder:Array
(
[0] => Array
(
[ApplNo] => 201739
[companyName] => KALEO INC
[docInserts] => ["",""]
[products] => [{"drugName":"AUVI-Q","activeIngredients":"EPINEPHRINE","strength":"EQ 0.3MG\/DELIVERY","dosageForm":"SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"AUVI-Q","activeIngredients":"EPINEPHRINE","strength":"EQ 0.15MG\/DELIVERY","dosageForm":"SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"AUVI-Q","activeIngredients":"EPINEPHRINE","strength":"EQ 0.1MG\/DELIVERY","dosageForm":"SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"09\/28\/2019","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201739s015lbl.pdf\"}]","notes":""},{"actionDate":"11\/17\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201739s008s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/17\/2017","submission":"SUPPL-8","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201739s008s009lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201739s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/201739s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"08\/10\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/201739s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201739Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/201739_auviQ_toc.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"09\/28\/2019","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201739s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/201739Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"11\/17\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201739s008s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/201739Orig1s008,s009ltr.pdf\"}]","notes":">"},{"actionDate":"11\/17\/2017","submission":"SUPPL-8","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201739s008s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/201739Orig1s008,s009ltr.pdf\"}]","notes":">"},{"actionDate":"12\/19\/2016","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/17\/2017","submission":"SUPPL-6","supplementCategories":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/201739Orig1s006ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"05\/18\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201739s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/201739Orig1s004ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/201739Orig1s004pkg.pdf\"}]","notes":">"},{"actionDate":"04\/22\/2015","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/22\/2014","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-09-28
)
)