FDA Orange Book · active-ingredient family
Dobutamine hydrochloride
Dobutamine hydrochloride: 4 brands, 12 generics; first approved Oct 19, 1993; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 12 ANDA applications approved.
Brands (NDA)
4
Generics (ANDA)
12
Listed patents
0
Presentations
24
Brand (NDA) products
Originator applications
- BAXTER HLTHCARENDA 02025519934 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/100ML INJECTABLE INJECTION Rx AP EQ 100MG BASE/100ML INJECTABLE INJECTION Rx AP EQ 200MG BASE/100ML INJECTABLE INJECTION Rx AP EQ 400MG BASE/100ML INJECTABLE INJECTION Rx AP - HOSPIRANDA 02020119934 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/100ML INJECTABLE INJECTION Rx AP EQ 100MG BASE/100ML INJECTABLE INJECTION Rx AP EQ 50MG BASE/100ML INJECTABLE INJECTION Rx AP EQ 400MG BASE/100ML INJECTABLE INJECTION Rx AP - DOBUTREXRLDLILLYNDA 017820—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12.5MG BASE/ML INJECTABLE INJECTION Discontinued — - HOSPIRANDA 02026919933 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/100ML INJECTABLE INJECTION Discontinued — EQ 100MG BASE/100ML INJECTABLE INJECTION Discontinued — EQ 200MG BASE/100ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (12)
Abbreviated applications
- DOBUTAMINE HYDROCHLORIDESLATE RUN PHARMAANDA 2161312022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12.5MG BASE/ML INJECTABLE INJECTION Rx AP - DOBUTAMINE HYDROCHLORIDELUITPOLDANDA 0745451998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12.5MG BASE/ML INJECTABLE INJECTION Discontinued — - DOBUTAMINE HYDROCHLORIDEDR REDDYSANDA 0749951998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12.5MG BASE/ML INJECTABLE INJECTION Discontinued — - DOBUTAMINE HYDROCHLORIDEWATSON LABS INCANDA 0742791998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12.5MG BASE/ML INJECTABLE INJECTION Discontinued — - DOBUTAMINE HYDROCHLORIDEHOSPIRAANDA 0746341996
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1.25GM BASE/100ML INJECTABLE INJECTION Discontinued — - DOBUTAMINE HYDROCHLORIDEBAXTER HLTHCAREANDA 0743811996
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12.5MG BASE/ML INJECTABLE INJECTION Discontinued — - DOBUTAMINE HYDROCHLORIDETELIGENTANDA 0740981995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12.5MG BASE/ML INJECTABLE INJECTION Discontinued — - DOBUTAMINE HYDROCHLORIDEHOSPIRAANDA 0742921995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12.5MG BASE/ML INJECTABLE INJECTION Discontinued — - DOBUTAMINE HYDROCHLORIDEHIKMAANDA 0742771994
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12.5MG BASE/ML INJECTABLE INJECTION Rx AP - DOBUTAMINE HYDROCHLORIDEWATSON LABSANDA 0741141993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12.5MG BASE/ML INJECTABLE INJECTION Discontinued — - DOBUTAMINE HYDROCHLORIDERSHOSPIRAANDA 0740861993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12.5MG BASE/ML INJECTABLE INJECTION Rx AP - DOBUTAMINE HYDROCHLORIDETEVA PARENTERALANDA 0742061993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12.5MG BASE/ML INJECTABLE INJECTION Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
33 yr 4 mo ago
Most recent approval
3 yr 9 mo ago
Approvals span 1993–2022 across 16 FDA applications.
Brand (NDA) 425%
Generic (ANDA) 1275%
Dobutamine hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
