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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017106-001ATROPENATROPINEEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, Approved before 1982
N017106-002ATROPENATROPINEEQ 1MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-19
N017106-003ATROPENATROPINEEQ 0.5MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-19
N017106-004ATROPENATROPINEEQ 0.25MG SULFATE/0.3MLSOLUTION / INTRAMUSCULARRLD2004-09-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017106-001ATROPENEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017106-002ATROPENEQ 1MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017106-003ATROPENEQ 0.5MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017106-004ATROPENEQ 0.25MG SULFATE/0.3MLSOLUTION / INTRAMUSCULARRLD2004-09-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017106-001ATROPENEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017106-002ATROPENEQ 1MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017106-003ATROPENEQ 0.5MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017106-004ATROPENEQ 0.25MG SULFATE/0.3MLSOLUTION / INTRAMUSCULARRLD2004-09-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017106-001ATROPENEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N017106-002ATROPENEQ 1MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N017106-003ATROPENEQ 0.5MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N017106-004ATROPENEQ 0.25MG SULFATE/0.3MLSOLUTION / INTRAMUSCULARRLD2004-09-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017106-001ATROPENEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017106-002ATROPENEQ 1MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017106-003ATROPENEQ 0.5MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017106-004ATROPENEQ 0.25MG SULFATE/0.3MLSOLUTION / INTRAMUSCULARRLD2004-09-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017106-001ATROPENEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017106-002ATROPENEQ 1MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017106-003ATROPENEQ 0.5MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017106-004ATROPENEQ 0.25MG SULFATE/0.3MLSOLUTION / INTRAMUSCULARRLD2004-09-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017106-001ATROPENEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017106-002ATROPENEQ 1MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017106-003ATROPENEQ 0.5MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017106-004ATROPENEQ 0.25MG SULFATE/0.3MLSOLUTION / INTRAMUSCULARRLD2004-09-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017106-001ATROPENEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N017106-002ATROPENEQ 1MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05N017106-003ATROPENEQ 0.5MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05N017106-004ATROPENEQ 0.25MG SULFATE/0.3MLSOLUTION / INTRAMUSCULARRLD2004-09-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017106-001ATROPENEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, RS, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017106-002ATROPENEQ 1MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, RS2003-06-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017106-003ATROPENEQ 0.5MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, RS2003-06-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017106-004ATROPENEQ 0.25MG SULFATE/0.3MLSOLUTION / INTRAMUSCULARRLD, RS2004-09-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017106-001ATROPENEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N017106-002ATROPENEQ 1MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, RS2003-06-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N017106-003ATROPENEQ 0.5MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, RS2003-06-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N017106-004ATROPENEQ 0.25MG SULFATE/0.3MLSOLUTION / INTRAMUSCULARRLD, RS2004-09-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017106-001ATROPENEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, RS, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N017106-002ATROPENEQ 1MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, RS2003-06-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N017106-003ATROPENEQ 0.5MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, RS2003-06-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N017106-004ATROPENEQ 0.25MG SULFATE/0.3MLSOLUTION / INTRAMUSCULARRLD, RS2004-09-174b0b4de00fa7…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATROPEN Auto-InjectorATROPINEMeridian Medical Technologies LLCe2d4307d-da8f-49f5-aac0-02355dd9ffb72022-09-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 017106
application number: NDA017106
ndc (product): 11704-107
ndc (product): 11704-105
ndc (product): 11704-104
ndc (product): 11704-101
ndc (product): 11704-106

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

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