Application 019615

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION80MG/100MLYesYes
002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION160MG/100MLYesYes
003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION320MG/100MLYesYes
004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION640MG/100MLYesYes

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

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
N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDE80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27
N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDE160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27
N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDE320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27
N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDE640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N019615-001AP
N019615-002AP
N019615-003AP

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-27d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N019615-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019615-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019615-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019615-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019615-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019615-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019615-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019615-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019615-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019615-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019615-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019615-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019615-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019615-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019615-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019615-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019615-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019615-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019615-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019615-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019615-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019615-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019615-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019615-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019615-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019615-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019615-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019615-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019615-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019615-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019615-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019615-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019615-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019615-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019615-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019615-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019615-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019615-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019615-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019615-001AP18072bd15b7f6…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dopamine Hydrochloride and DextroseDOPAMINE HYDROCHLORIDEProPharma Distribution3ef116db-fb26-1e66-e063-6294a90a06102025-12-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 019615
application number: NDA019615
Dopamine Hydrochloride and DextroseDOPAMINE HYDROCHLORIDEBaxter Healthcare Corporationcb97d4a0-89ed-407c-a763-209386b6f75c2020-11-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 019615
application number: NDA019615
ndc (product): 0338-1009
ndc (product): 0338-1005
ndc (product): 0338-1007

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-1005Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1005Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1005Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1005Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1005Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1007Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1007Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1007Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1007Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1007Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1009Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1009Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1009Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1009Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1009Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65591SUPPL2020-12-15
49079SUPPL2017-07-25
49055SUPPL2017-07-25
11563SUPPL2012-06-18
1418SUPPL2012-06-18
17485SUPPL2012-03-15
17483SUPPL2007-07-05
17484SUPPL2002-06-20
20266SUPPL2001-04-17
17482SUPPL2001-04-17