Orange Book product · Brand (NDA)
COSMEGEN
DACTINOMYCIN
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
DACTINOMYCIN
Strength
0.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 050682
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2020DACTINOMYCINGeneric (ANDA)
ANDA 213463 · MEITHEAL
- 2019DACTINOMYCINGeneric (ANDA)
ANDA 207232 · HISUN PHARM HANGZHOU
- 2019DACTINOMYCINGeneric (ANDA)
ANDA 203999 · XGEN PHARMS
- 2017DACTINOMYCINGeneric (ANDA)
ANDA 203385 · EUGIA PHARMA
- 2013DACTINOMYCINGeneric (ANDA)
ANDA 202562 · AM REGENT
- 2010DACTINOMYCINGeneric (ANDA)
ANDA 090304 · HIKMA
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.
