Application 201739

Type: NDA
Sponsor: KALEO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AUVI-Q	EPINEPHRINE	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	EQ 0.3MG/DELIVERY	Yes	No
002	AUVI-Q	EPINEPHRINE	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	EQ 0.15MG/DELIVERY	Yes	Yes
003	AUVI-Q	EPINEPHRINE	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	EQ 0.1MG/DELIVERY	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51662-1320	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1320	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1320	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1320	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1320	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1321	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1321	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1321	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1321	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1321	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1476	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1476	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1476	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
60842-021	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-021	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-021	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-021	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-021	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-022	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-022	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-022	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-022	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-022	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-023	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-023	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-023	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-023	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-023	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
71872-7172	Auvi-Q	epinephrine	Medical Purchasing Solutions, LLC	NDA	Current
71872-7173	Auvi-Q	epinephrine	Medical Purchasing Solutions, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82141	SUPPL	2025-05-05
82286	SUPPL	2025-04-30
77674	SUPPL	2024-02-29
77659	SUPPL	2024-02-29
60183	SUPPL	2019-10-01
60168	SUPPL	2019-10-01
50458	SUPPL	2017-11-17
50457	SUPPL	2017-11-17
50456	SUPPL	2017-11-17
50455	SUPPL	2017-11-17
47296	SUPPL	2017-02-23
47091	SUPPL	2017-02-02
40084	SUPPL	2016-05-20
32133	SUPPL	2016-05-19
43373	ORIG	2012-12-04
19033	ORIG	2012-08-15
32132	ORIG	2012-08-14
52479	ORIG	1900-01-01

Application 201739

Related Records#

Application Products#

NDC Listings For This Application#

Documents#