Application 020255

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOBUTAMINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 50MG BASE/100MLYesYes
003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOBUTAMINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 100MG BASE/100MLYesYes
004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOBUTAMINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 200MG BASE/100MLYesYes
005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOBUTAMINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 400MG BASE/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
N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOBUTAMINE HYDROCHLORIDEEQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19
N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOBUTAMINE HYDROCHLORIDEEQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19
N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOBUTAMINE HYDROCHLORIDEEQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19
N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOBUTAMINE HYDROCHLORIDEEQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N020255-001AP
N020255-003AP
N020255-004AP
N020255-005AP

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 UTC2026-02N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020255-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020255-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020255-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020255-005AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020255-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020255-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020255-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020255-005AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020255-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020255-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020255-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020255-005AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020255-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020255-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020255-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020255-005AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020255-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020255-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020255-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020255-005AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020255-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020255-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020255-004AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020255-005AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020255-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020255-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020255-004AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020255-005AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020255-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020255-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020255-004AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020255-005AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020255-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020255-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020255-004AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020255-005AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020255-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020255-003AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020255-004AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020255-005AP1d06236e962d9…

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
DOBUTAMINE HYDROCHLORIDEDOBUTAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstc6ceb8d3-e46e-f0da-e053-2995a90a8c3c2024-01-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 020255
application number: NDA020255
ndc (product): 51662-1566
Dobutamine Hydrochloride in DextroseDOBUTAMINE HYDROCHLORIDEBaxter Healthcare Corporation6b17b98b-e06d-42ed-925f-69aa2699dead2023-09-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 020255
application number: NDA020255
ndc (product): 0338-1073
ndc (product): 0338-1075
ndc (product): 0338-1077

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-1073Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1073Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1073Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1073Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporaNDACurrent
0338-1073Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1075Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1075Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1075Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1075Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporaNDACurrent
0338-1075Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1077Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1077Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1077Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1077Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporaNDACurrent
0338-1077Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
50090-4562Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideA-S Medication SolutionsNDACurrent
50090-4562Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideA-S Medication SolutionsNDACurrent
50090-4562Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideA-S Medication SolutionsNDACurrent
51662-1566DOBUTAMINE HYDROCHLORIDEDOBUTAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75385SUPPL 2023-09-11
75277SUPPL 2023-08-24
66069SUPPL2021-02-03
58257SUPPL2019-04-08
58131SUPPL2019-03-28
24667SUPPL2013-04-23
12377SUPPL2013-04-19
2253SUPPL2012-03-12
24666SUPPL2003-07-28
2252SUPPL2003-07-28
20558SUPPL2000-06-14