FDA Orange Book · active-ingredient family
Dactinomycin
Dactinomycin: 1 brand, 6 generics; first approved Mar 16, 2010; 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
7
Brand (NDA) products
Originator applications
- COSMEGENRLDRECORDATI RARENDA 050682—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (6)
Abbreviated applications
- DACTINOMYCINMEITHEALANDA 2134632020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/VIAL INJECTABLE INJECTION Rx AP - DACTINOMYCINHISUN PHARM HANGZHOUANDA 2072322019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/VIAL INJECTABLE INJECTION Rx AP - DACTINOMYCINXGEN PHARMSANDA 2039992019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/VIAL INJECTABLE INJECTION Rx AP - DACTINOMYCINRSEUGIA PHARMAANDA 2033852017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/VIAL INJECTABLE INJECTION Rx AP - DACTINOMYCINAM REGENTANDA 2025622013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/VIAL INJECTABLE INJECTION Discontinued — - DACTINOMYCINHIKMAANDA 0903042010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/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
16 yr 8 mo ago
Most recent approval
5 yr 10 mo ago
Approvals span 2010–2020 across 7 FDA applications.
Brand (NDA) 114%
Generic (ANDA) 686%
Dactinomycin: 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.
