Orange Book product · Generic (ANDA)
DACTINOMYCIN
DACTINOMYCIN
Generic (ANDA)ANDA 203385TE APRX EUGIA PHARMA
At a glance
Nov 09, 2017
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 09, 2017
8 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
DACTINOMYCIN
Strength
0.5MG/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 203385
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of DACTINOMYCIN
- —COSMEGENBrand (NDA)
NDA 050682 · RECORDATI RARE
- 2020DACTINOMYCINGeneric (ANDA)
ANDA 213463 · MEITHEAL
- 2019DACTINOMYCINGeneric (ANDA)
ANDA 207232 · HISUN PHARM HANGZHOU
- 2019DACTINOMYCINGeneric (ANDA)
ANDA 203999 · XGEN PHARMS
- 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.
