Orange Book product · Generic (ANDA)
DACTINOMYCIN
DACTINOMYCIN
Generic (ANDA)ANDA 203999TE APRX XGEN PHARMS
At a glance
May 20, 2019
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 20, 2019
7 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
DACTINOMYCIN
Strength
0.5MG/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 203999
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
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
- 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.
