Home Applications 074292 Application 074292
Type ANDA
Sponsor HOSPIRA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DOBUTAMINE HYDROCHLORIDE DOBUTAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 12.5MG BASE/ML No Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074292-001 DOBUTAMINE HYDROCHLORIDE DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1995-02-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1995-02-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1995-02-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1995-02-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074292-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION 1995-02-16 cb3db0bc1861…
Observed Orange Book normalized TE history# 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0409-2025 DOBUTAMINE DOBUTAMINE Hospira, Inc. ANDA Current 0409-2025 DOBUTAMINE DOBUTAMINE Hospira, Inc. ANDA Current 0409-2025 DOBUTAMINE DOBUTAMINE Hospira, Inc. ANDA Current 52584-048 Dobutamine Dobutamine Hydrochloride Injection General Injectables and Vaccines, Inc. ANDA Current