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 42.

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 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N017106-001ATROPENEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N017106-002ATROPENEQ 1MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-19caaa826d4ba7…
2026-08-18 06:07:402026-07N017106-003ATROPENEQ 0.5MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-19caaa826d4ba7…
2026-08-18 06:07:402026-07N017106-004ATROPENEQ 0.25MG SULFATE/0.3MLSOLUTION / INTRAMUSCULARRLD2004-09-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017106-001ATROPENEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017106-002ATROPENEQ 1MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017106-003ATROPENEQ 0.5MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017106-004ATROPENEQ 0.25MG SULFATE/0.3MLSOLUTION / INTRAMUSCULARRLD2004-09-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017106-001ATROPENEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017106-002ATROPENEQ 1MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017106-003ATROPENEQ 0.5MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017106-004ATROPENEQ 0.25MG SULFATE/0.3MLSOLUTION / INTRAMUSCULARRLD2004-09-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N017106-001ATROPENEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017106-002ATROPENEQ 1MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017106-003ATROPENEQ 0.5MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017106-004ATROPENEQ 0.25MG SULFATE/0.3MLSOLUTION / INTRAMUSCULARRLD2004-09-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017106-001ATROPENEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017106-002ATROPENEQ 1MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017106-003ATROPENEQ 0.5MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017106-004ATROPENEQ 0.25MG SULFATE/0.3MLSOLUTION / INTRAMUSCULARRLD2004-09-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017106-001ATROPENEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017106-002ATROPENEQ 1MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017106-003ATROPENEQ 0.5MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017106-004ATROPENEQ 0.25MG SULFATE/0.3MLSOLUTION / INTRAMUSCULARRLD2004-09-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017106-001ATROPENEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017106-002ATROPENEQ 1MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017106-003ATROPENEQ 0.5MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017106-004ATROPENEQ 0.25MG SULFATE/0.3MLSOLUTION / INTRAMUSCULARRLD2004-09-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017106-001ATROPENEQ 2MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017106-002ATROPENEQ 1MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017106-003ATROPENEQ 0.5MG SULFATE/0.7MLSOLUTION / INTRAMUSCULARRLD2003-06-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017106-004ATROPENEQ 0.25MG SULFATE/0.3MLSOLUTION / INTRAMUSCULARRLD2004-09-172680178bc6a6…
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…

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

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