FDA.reportPublic FDA data

Application 017106

Type
NDA
Sponsor
MERIDIAN MEDCL TECHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATROPENATROPINESOLUTION;INTRAMUSCULAREQ 2MG SULFATE/0.7MLYesYes
002ATROPENATROPINESOLUTION;INTRAMUSCULAREQ 1MG SULFATE/0.7MLYesYes
003ATROPENATROPINESOLUTION;INTRAMUSCULAREQ 0.5MG SULFATE/0.7MLYesYes
004ATROPENATROPINESOLUTION;INTRAMUSCULAREQ 0.25MG SULFATE/0.3MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11704-101ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-101ATROPEN Auto-InjectoratropineMeridian Medical Technologies LLCNDACurrent
11704-101ATROPEN Auto-InjectoratropineMeridian Medical Technologies LLCNDACurrent
11704-101ATROPEN Auto-InjectoratropineMeridian Medical Technologies LLCNDACurrent
11704-101ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-101ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-101ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-104ATROPEN Auto-InjectoratropineMeridian Medical Technologies LLCNDACurrent
11704-104ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-104ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-104ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-104ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-104ATROPEN Auto-InjectoratropineMeridian Medical Technologies LLCNDACurrent
11704-104ATROPEN Auto-InjectoratropineMeridian Medical Technologies LLCNDACurrent
11704-104AtroPen Auto-InjectorAtropine sulfateMeridian Medical Technologies, Inc.NDACurrent
11704-105AtroPen Auto-InjectorAtropine sulfateMeridian Medical Technologies, Inc.NDACurrent
11704-105ATROPEN Auto-InjectoratropineMeridian Medical Technologies LLCNDACurrent
11704-105ATROPEN Auto-InjectoratropineMeridian Medical Technologies LLCNDACurrent
11704-105ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-105ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-105ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-105ATROPEN Auto-InjectoratropineMeridian Medical Technologies LLCNDACurrent
11704-105ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-106ATROPEN Auto-InjectoratropineMeridian Medical Technologies LLCNDACurrent
11704-106AtroPen Auto-InjectorAtropine sulfateMeridian Medical Technologies, Inc.NDACurrent
11704-106ATROPEN Auto-InjectoratropineMeridian Medical Technologies LLCNDACurrent
11704-106ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-106ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-106ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-106ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-106ATROPEN Auto-InjectoratropineMeridian Medical Technologies LLCNDACurrent
11704-107ATROPEN Auto-InjectoratropineMeridian Medical Technologies LLCNDACurrent
11704-107ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-107ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-107ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-107ATROPEN Auto-InjectoratropineMeridian Medical Technologies, Inc.NDACurrent
11704-107ATROPEN Auto-InjectoratropineMeridian Medical Technologies LLCNDACurrent
11704-107ATROPEN Auto-InjectoratropineMeridian Medical Technologies LLCNDACurrent
11704-107AtroPen Auto-InjectorAtropine sulfateMeridian Medical Technologies, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65304SUPPL2020-11-25
65300SUPPL2020-11-23
33228SUPPL2004-09-21
13090SUPPL2004-09-21
33227SUPPL2003-06-25
13089SUPPL2003-06-25