FDA.reportPublic FDA data

Application 021983

Type
NDA
Sponsor
MERIDIAN MEDCL

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021983-001DUODOTEATROPINE; PRALIDOXIME CHLORIDE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-28

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-283f01610625f2…
2019-09-15 20:21 UTC2019-09N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021983-001DUODOTE2.1MG/0.7ML;600MG/2MLINJECTABLE / INTRAMUSCULARRLD, RS2006-09-28cb3db0bc1861…

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
DuoDoteATROPINE AND PRALIDOXIME CHLORIDEMeridian Medical Technologies LLC241f42a0-1a33-40e8-8221-201767d999e52022-04-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 021983
application number: NDA021983
ndc (product): 11704-620

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11704-620DuoDoteatropine and pralidoxime chlorideMeridian Medical Technologies, Inc.NDACurrent
11704-620DuoDoteatropine and pralidoxime chlorideMeridian Medical Technologies, Inc.NDACurrent
11704-620DuoDoteatropine and pralidoxime chlorideMeridian Medical Technologies LLCNDACurrent
11704-620DuoDoteatropine and pralidoxime chlorideMeridian Medical Technologies, Inc.NDACurrent
11704-620DuoDoteatropine and pralidoxime chlorideMeridian Medical Technologies, Inc.NDACurrent
11704-620DuoDoteatropine and pralidoxime chlorideMeridian Medical TechnologiesNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71102SUPPL2022-05-19
71089SUPPL2022-05-18
50013SUPPL2017-10-11
49997SUPPL2017-10-10
21894ORIG2009-07-15
6583ORIG2006-10-02
51751SUPPL1900-01-01
51750SUPPL1900-01-01
51749SUPPL1900-01-01