FDA.reportPublic FDA data

Application 021175

Type
NDA
Sponsor
US ARMY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATNAAATROPINE; PRALIDOXIME CHLORIDEINJECTABLE;INTRAMUSCULAR2.1MG/0.7ML;600MG/2MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021175-001ATNAAATROPINE; PRALIDOXIME CHLORIDE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-17

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-1787673890dc5c…
2021-03-12 10:30 UTC2021-03N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-173f01610625f2…
2019-09-15 20:21 UTC2019-09N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-173f0d92c62455…
2023-05-13 08:27 UTC2023-05N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-17053a50430f4f…
2023-01-26 05:58 UTC2023-01N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021175-001ATNAA2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULAR2002-01-17e64feba35796…

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
ATNAA atropine and pralidoxime chloride Auto-InjectorATROPINE AND PRALIDOXIME CHLORIDEMeridian Medical Technologies, LLC596c7a8f-27cd-4de2-9491-476f43570b8b2022-07-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 021175
application number: NDA021175
ndc (product): 11704-777

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11704-777ATNAA atropine and pralidoxime chlorideatropine and pralidoxime chlorideMeridian Medical Technologies, Inc.NDACurrent
11704-777ATNAA atropine and pralidoxime chlorideatropine and pralidoxime chlorideMeridian Medical Technologies, Inc.NDACurrent
11704-777ATNAA atropine and pralidoxime chlorideatropine and pralidoxime chlorideMeridian Medical Technologies, Inc.NDACurrent
11704-777ATNAA atropine and pralidoxime chlorideatropine and pralidoxime chlorideMeridian Medical Technologies, Inc.NDACurrent
11704-777ATNAA atropine and pralidoxime chlorideatropine and pralidoxime chlorideMeridian Medical Technologies LLCNDACurrent
11704-777ATNAA atropine and pralidoxime chlorideatropine and pralidoxime chlorideMeridian Medical Technologies LLCNDACurrent
11704-777ATNAA atropine and pralidoxime chlorideatropine and pralidoxime chlorideMeridian Medical Technologies, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71189SUPPL2022-06-01
71165SUPPL2022-05-31
63316SUPPL2020-05-28
63291SUPPL2020-05-26
42001ORIG2004-05-27
26991ORIG2002-01-17
14571ORIG2002-01-17