FDA.reportPublic FDA data

Application 208411

Type
NDA
Sponsor
ADAPT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NARCANNALOXONE HYDROCHLORIDESPRAY, METERED;NASAL4MG/SPRAYYesYes
002NARCANNALOXONE HYDROCHLORIDESPRAY, METERED;NASAL2MG/SPRAYYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-7176Naloxone HydrochlorideNaloxone Hydrochloride Nasal SpraySandoz Inc.NDACurrent
0781-7176Naloxone HydrochlorideNaloxone Hydrochloride Nasal SpraySandoz Inc.NDA AUTHORIZED GENERICCurrent
50090-2422NarcanNaloxone HydrochlorideA-S Medication SolutionsNDACurrent
50090-2422NarcanNaloxone HydrochlorideA-S Medication SolutionsNDACurrent
50090-2422NarcanNaloxone HydrochlorideA-S Medication SolutionsNDACurrent
50090-5908Naloxone HydrochlorideNaloxone Hydrochloride NasalA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
51662-1240NARCAN NALOXONE HCINARCAN NALOXONE HCIHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1240NARCAN NALOXONE HCINARCAN NALOXONE HCIHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1240NARCAN NALOXONE HCINARCAN NALOXONE HCIHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1240NARCAN NALOXONE HCINARCAN NALOXONE HCIHF Acquisition Co LLC, DBA HealthFirstNDACurrent
55700-457NARCANnaloxone hydrochlorideLake Erie Medical DBA Quality Care Products LLCNDACurrent
55700-457NARCANnaloxone hydrochlorideLake Erie Medical DBA Quality Care Products LLCNDACurrent
55700-457NARCANnaloxone hydrochlorideLake Erie Medical DBA Quality Care Products LLCNDACurrent
55700-457NARCANnaloxone hydrochlorideLake Erie Medical DBA Quality Care Products LLCNDACurrent
55700-985Naloxone HydrochlorideNaloxone Hydrochloride Nasal SprayQuality Care Products, LLCNDA AUTHORIZED GENERICCurrent
69547-212Narcannaloxone hydrochlorideEmergent Devices Inc.NDACurrent
69547-212Narcannaloxone hydrochlorideEmergent Devices Inc.NDACurrent
69547-212Narcannaloxone hydrochlorideAdapt Pharma IncNDACurrent
69547-212Narcannaloxone hydrochlorideAdapt Pharma IncNDACurrent
69547-212Narcannaloxone hydrochlorideAdapt Pharma IncNDACurrent
69547-353NarcanNaloxone HydrochlorideEmergent Devices Inc.NDACurrent
69547-353NarcanNaloxone HydrochlorideEmergent Devices Inc.NDACurrent
69547-353NarcanNaloxone HydrochlorideAdapt Pharma IncNDACurrent
69547-353NarcanNaloxone HydrochlorideAdapt Pharma IncNDACurrent
69547-353NarcanNaloxone HydrochlorideAdapt Pharma IncNDACurrent
71205-528NarcanNaloxone HydrochlorideProficient Rx LPNDACurrent
71205-528NarcanNaloxone HydrochlorideProficient Rx LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85035SUPPL 2026-02-12
85034SUPPL 2026-02-12
84773SUPPL 2026-01-16
84772SUPPL 2026-01-16
84274SUPPL 2025-11-24
84273SUPPL 2025-11-24
74016SUPPL 2023-04-19
73900SUPPL 2023-03-29
73899SUPPL 2023-03-29
73893SUPPL 2023-03-28
73888SUPPL 2023-03-28
64613SUPPL2020-09-18
64585SUPPL2020-09-16
60171SUPPL2019-10-01
46993SUPPL2017-01-27
46990SUPPL2017-01-27
46979SUPPL2017-01-24
43546ORIG2016-07-28
32908ORIG2015-11-19
40633ORIG2015-11-18
51393ORIG1900-01-01
51392ORIG1900-01-01
51391ORIG1900-01-01