Application 019099

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION40MG/100MLYesYes
002DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%DOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION80MG/100MLYesYes
003DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION160MG/100MLYesYes
004DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%DOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION320MG/100MLYesYes

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
N019099-001DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDE40MG/100MLINJECTABLE / INJECTIONRLD1986-10-15
N019099-002DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%DOPAMINE HYDROCHLORIDE80MG/100MLINJECTABLE / INJECTIONRLD1986-10-15
N019099-003DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDE160MG/100MLINJECTABLE / INJECTIONRLD1986-10-15
N019099-004DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%DOPAMINE HYDROCHLORIDE320MG/100MLINJECTABLE / INJECTIONRLD1986-10-15

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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N019099-001DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER40MG/100MLINJECTABLE / INJECTIONRLD1986-10-15c2088c7a36db…
2026-10-15 13:18:302026-09N019099-002DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%80MG/100MLINJECTABLE / INJECTIONRLD1986-10-15c2088c7a36db…
2026-10-15 13:18:302026-09N019099-003DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONRLD1986-10-15c2088c7a36db…
2026-10-15 13:18:302026-09N019099-004DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%320MG/100MLINJECTABLE / INJECTIONRLD1986-10-15c2088c7a36db…
2026-09-14 22:38:342026-08N019099-001DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER40MG/100MLINJECTABLE / INJECTIONRLD1986-10-1584e616aacf4f…
2026-09-14 22:38:342026-08N019099-002DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%80MG/100MLINJECTABLE / INJECTIONRLD1986-10-1584e616aacf4f…
2026-09-14 22:38:342026-08N019099-003DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONRLD1986-10-1584e616aacf4f…
2026-09-14 22:38:342026-08N019099-004DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%320MG/100MLINJECTABLE / INJECTIONRLD1986-10-1584e616aacf4f…
2026-08-18 06:07:402026-07N019099-001DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER40MG/100MLINJECTABLE / INJECTIONRLD1986-10-15caaa826d4ba7…
2026-08-18 06:07:402026-07N019099-002DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%80MG/100MLINJECTABLE / INJECTIONRLD1986-10-15caaa826d4ba7…
2026-08-18 06:07:402026-07N019099-003DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONRLD1986-10-15caaa826d4ba7…
2026-08-18 06:07:402026-07N019099-004DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%320MG/100MLINJECTABLE / INJECTIONRLD1986-10-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019099-001DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER40MG/100MLINJECTABLE / INJECTIONRLD1986-10-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019099-002DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%80MG/100MLINJECTABLE / INJECTIONRLD1986-10-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019099-003DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONRLD1986-10-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019099-004DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%320MG/100MLINJECTABLE / INJECTIONRLD1986-10-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019099-001DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER40MG/100MLINJECTABLE / INJECTIONRLD1986-10-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019099-002DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%80MG/100MLINJECTABLE / INJECTIONRLD1986-10-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019099-003DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONRLD1986-10-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019099-004DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%320MG/100MLINJECTABLE / INJECTIONRLD1986-10-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N019099-001DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER40MG/100MLINJECTABLE / INJECTIONRLD1986-10-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019099-002DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%80MG/100MLINJECTABLE / INJECTIONRLD1986-10-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019099-003DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONRLD1986-10-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019099-004DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%320MG/100MLINJECTABLE / INJECTIONRLD1986-10-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019099-001DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER40MG/100MLINJECTABLE / INJECTIONRLD1986-10-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019099-002DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%80MG/100MLINJECTABLE / INJECTIONRLD1986-10-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019099-003DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONRLD1986-10-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019099-004DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%320MG/100MLINJECTABLE / INJECTIONRLD1986-10-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019099-001DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER40MG/100MLINJECTABLE / INJECTIONRLD1986-10-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019099-002DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%80MG/100MLINJECTABLE / INJECTIONRLD1986-10-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019099-003DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONRLD1986-10-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019099-004DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%320MG/100MLINJECTABLE / INJECTIONRLD1986-10-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019099-001DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER40MG/100MLINJECTABLE / INJECTIONRLD1986-10-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019099-002DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%80MG/100MLINJECTABLE / INJECTIONRLD1986-10-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019099-003DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONRLD1986-10-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019099-004DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%320MG/100MLINJECTABLE / INJECTIONRLD1986-10-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019099-001DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER40MG/100MLINJECTABLE / INJECTIONRLD1986-10-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019099-002DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%80MG/100MLINJECTABLE / INJECTIONRLD1986-10-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019099-003DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONRLD1986-10-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019099-004DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%320MG/100MLINJECTABLE / INJECTIONRLD1986-10-152680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 57 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019099-002AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019099-003AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019099-004AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019099-002AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019099-003AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019099-004AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019099-002AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019099-003AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019099-004AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019099-002AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019099-003AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019099-004AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019099-002AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019099-003AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019099-004AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019099-002AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12N019099-003AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12N019099-004AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019099-002AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019099-003AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019099-004AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N019099-002AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N019099-003AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N019099-004AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019099-002AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N019099-003AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N019099-004AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019099-002AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N019099-003AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N019099-004AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019099-002AP13f01610625f2…
2019-12-14 00:12 UTC2019-12N019099-003AP13f01610625f2…
2019-12-14 00:12 UTC2019-12N019099-004AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N019099-002AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09N019099-003AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09N019099-004AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N019099-002AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07N019099-003AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07N019099-004AP1ea99ee380514…
2023-05-13 08:27 UTC2023-05N019099-002AP1053a50430f4f…

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOPamine HydrochlorideDOPAMINE HYDROCHLORIDEHospira, Inc.1f306ad2-3606-4525-5a8a-ce78f426c1a22026-05-13Warnings, Adverse reactionsName fallback
generic name: DOPAMINE HYDROCHLORIDE
DopamineDOPAMINE HYDROCHLORIDEBioActive Nutritional, Inc.5346622d-9719-493a-90f4-21f540d6cb2a2026-03-30WarningsName fallback
generic name: DOPAMINE HYDROCHLORIDE
Dopamine Hydrochloride and DextroseDOPAMINE HYDROCHLORIDEProPharma Distribution3ef116db-fb26-1e66-e063-6294a90a06102025-12-18Warnings, Adverse reactionsName fallback
generic name: DOPAMINE HYDROCHLORIDE
DOPamine HydrochlorideDOPAMINE HYDROCHLORIDEProPharma Distribution45b0729e-529b-02f6-e063-6294a90a31d32025-12-11Warnings, Adverse reactionsName fallback
generic name: DOPAMINE HYDROCHLORIDE
Dopamine HydrochlorideDOPAMINE HYDROCHLORIDEHenry Schein, Inc.fc1eb709-ce72-413e-9043-8e463ef0fd362025-10-30Warnings, Adverse reactionsName fallback
generic name: DOPAMINE HYDROCHLORIDE
Dopamine HydrochlorideDOPAMINE HYDROCHLORIDEHenry Schein, Inc.460906f7-b532-4ddb-a799-ad7b504881432025-08-05Warnings, Adverse reactionsName fallback
generic name: DOPAMINE HYDROCHLORIDE
Dopamine HydrochlorideDOPAMINE HYDROCHLORIDEProPharma Distribution38431050-007e-41b2-e063-6394a90a1d642025-07-18Warnings, Adverse reactionsName fallback
generic name: DOPAMINE HYDROCHLORIDE
DOPAMINE PHENOLICDOPAMINE HYDROCHLORIDEEnergique, Inc.d10ca5bc-2612-4589-a49c-1b9935fa0bf32024-10-24WarningsName fallback
generic name: DOPAMINE HYDROCHLORIDE
Dopamine HydrochlorideDOPAMINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.0e499952-46c7-4172-8c70-186312e240a32024-04-15Warnings, Adverse reactionsName fallback
generic name: DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstc901b461-4f98-da0a-e053-2a95a90a106e2024-02-22Warnings, Adverse reactionsName fallback
generic name: DOPAMINE HYDROCHLORIDE
DopamineDOPAMINE HYDROCHLORIDEDeseret Biologicals, Inc.b984b509-cdeb-4fc9-8133-be3b7ba82c8c2024-02-20WarningsName fallback
generic name: DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstc6c8539b-0da9-2d97-e053-2a95a90a3aa82024-02-19Warnings, Adverse reactionsName fallback
generic name: DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst7896052c-2a72-ca89-e053-2a91aa0ae86e2024-01-29Warnings, Adverse reactionsName fallback
generic name: DOPAMINE HYDROCHLORIDE
Dopamine HydrochlorideDOPAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLC093312af-6eef-1f4b-e063-6294a90a155d2023-11-02Warnings, Adverse reactionsName fallback
generic name: DOPAMINE HYDROCHLORIDE
DOPamine HydrochlorideDOPAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLCb61fffd0-7bc8-09e2-e053-2995a90ae0e42023-05-30Warnings, Adverse reactionsName fallback
generic name: DOPAMINE HYDROCHLORIDE
Dopamine Hydrochloride and DextroseDOPAMINE HYDROCHLORIDEBaxter Healthcare Corporationcb97d4a0-89ed-407c-a763-209386b6f75c2020-11-11Warnings, Adverse reactionsName fallback
generic name: DOPAMINE HYDROCHLORIDE
DopamineDOPAMINE HYDROCHLORIDEBioActive Nutritional2e456b07-8b7b-463a-8cf5-1d7a51985b062016-08-16WarningsName fallback
generic name: DOPAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
1227SUPPL2005-01-11