FDA Orange Book · active-ingredient family
Dacarbazine
Dacarbazine: 1 brand, 6 generics; first approved Aug 28, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
6
Listed patents
0
Presentations
11
Brand (NDA) products
Originator applications
- DTIC-DOMERLDBAYER HLTHCARENDA 017575—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Discontinued — 200MG/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (6)
Abbreviated applications
- DACARBAZINEHOSPIRAANDA 0759402001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/VIAL INJECTABLE INJECTION Discontinued — - DACARBAZINEHIKMAANDA 07581220012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/VIAL INJECTABLE INJECTION Rx AP 500MG/VIAL INJECTABLE INJECTION Rx AP - DACARBAZINERSFRESENIUS KABI USAANDA 07537119992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Rx — 200MG/VIAL INJECTABLE INJECTION Rx AP - DACARBAZINEMEITHEALANDA 07525919982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP 200MG/VIAL INJECTABLE INJECTION Rx AP - DACARBAZINEABRAXIS PHARMANDA 0709621986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Discontinued — - DACARBAZINEABRAXIS PHARMANDA 0709901986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/VIAL 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
40 yr 8 mo ago
Most recent approval
24 yr 3 mo ago
Approvals span 1986–2002 across 7 FDA applications.
Brand (NDA) 114%
Generic (ANDA) 686%
Dacarbazine: 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.
