FDA Orange Book · active-ingredient family
Dopamine hydrochloride
Dopamine hydrochloride: 11 brands, 26 generics; first approved Feb 04, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 26 ANDA applications approved.
Brands (NDA)
11
Generics (ANDA)
26
Listed patents
0
Presentations
52
Brand (NDA) products
Originator applications
- BAXTER HLTHCARENDA 01961519874 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG/100ML INJECTABLE INJECTION Rx AP 160MG/100ML INJECTABLE INJECTION Rx AP 320MG/100ML INJECTABLE INJECTION Rx AP 640MG/100ML INJECTABLE INJECTION Rx — - B BRAUNNDA 01909919864 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/100ML INJECTABLE INJECTION Discontinued — 80MG/100ML INJECTABLE INJECTION Discontinued — 160MG/100ML INJECTABLE INJECTION Discontinued — 320MG/100ML INJECTABLE INJECTION Discontinued — - HOSPIRANDA 01882619833 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG/100ML INJECTABLE INJECTION Rx AP 160MG/100ML INJECTABLE INJECTION Rx AP 320MG/100ML INJECTABLE INJECTION Rx AP - DOPAMINE HYDROCHLORIDERLDRSHOSPIRANDA 018132—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Rx AP 80MG/100ML INJECTABLE INJECTION Rx AP 160MG/100ML INJECTABLE INJECTION Rx AP 80MG/ML INJECTABLE INJECTION Rx AP - HOSPIRANDA 0205421995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.6MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDETELIGENTNDA 0186561983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDELYPHOMEDNDA 0185491983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEBAXTER HLTHCARENDA 018398—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — 80MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEINTL MEDICATIONNDA 018014—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEWARNER CHILCOTTNDA 018138—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — - HOSPIRANDA 017395—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — 80MG/ML INJECTABLE INJECTION Discontinued — 160MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (26)
Abbreviated applications
- DOPAMINE HYDROCHLORIDEHIKMA INTL PHARMSANDA 20770720182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Rx AP 80MG/ML INJECTABLE INJECTION Rx AP - DOPAMINE HYDROCHLORIDEHOSPIRAANDA 0744031996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDETEVA PARENTERALANDA 0729991991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDETEVA PARENTERALANDA 0730001991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEABBOTTANDA 0706561989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEABBOTTANDA 0706571989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEAM REGENTANDA 0707991987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEAM REGENTANDA 0708201987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEAM REGENTANDA 0708261987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 160MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEABRAXIS PHARMANDA 0703641985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 160MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEIGI LABS INCANDA 0700871985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEIGI LABS INCANDA 0700891985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEIGI LABS INCANDA 0700901985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEIGI LABS INCANDA 0700911985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEIGI LABS INCANDA 0700921985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 160MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEIGI LABS INCANDA 0700931985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 160MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEIGI LABS INCANDA 0700941985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 160MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEWARNER CHILCOTTANDA 0705581985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEWARNER CHILCOTTANDA 0705591985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDESMITH AND NEPHEWANDA 0700111985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDESMITH AND NEPHEWANDA 0700461985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDESMITH AND NEPHEWANDA 0700471985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEABRAXIS PHARMANDA 0700121985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEABRAXIS PHARMANDA 0700131985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEABRAXIS PHARMANDA 0700581985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — - DOPAMINE HYDROCHLORIDEABRAXIS PHARMANDA 0700591985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG/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
45 yr 2 mo ago
Most recent approval
8 yr 6 mo ago
Approvals span 1982–2018 across 37 FDA applications.
Brand (NDA) 1130%
Generic (ANDA) 2670%
Dopamine 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.
