FDA Orange Book · active-ingredient family
Dactinomycin
Dactinomycin is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:COSMEGEN · NDA 050682
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COSMEGENRLD | RECORDATI RARE | NDA 050682 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DACTINOMYCIN | MEITHEAL | ANDA 213463 | AP | Nov 13, 2020 | |
| DACTINOMYCIN | HISUN PHARM HANGZHOU | ANDA 207232 | AP | Jul 16, 2019 | |
| DACTINOMYCIN | XGEN PHARMS | ANDA 203999 | AP | May 20, 2019 | |
| DACTINOMYCIN | EUGIA PHARMA | ANDA 203385 | AP | Nov 09, 2017 | |
| DACTINOMYCIN | AM REGENT | ANDA 202562 | — | Aug 23, 2013 | |
| DACTINOMYCIN | HIKMA | ANDA 090304 | — | Mar 16, 2010 |
Listed patents
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.
Dactinomycin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
