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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201739
Company: KALEO INC

Products on NDA 201739

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201739

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.

Labels for NDA 201739

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

Therapeutic Equivalents for NDA 201739

AUVI-Q

There are no Therapeutic Equivalents.

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