Orange Book product · Generic (ANDA)
DACTINOMYCIN
DACTINOMYCIN
At a glance
Aug 23, 2013
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 23, 2013
13 yr ago
Today
Pharmaceutical detail
Active ingredient
DACTINOMYCIN
Strength
0.5MG/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 202562
Product number
001
Marketing status
DISCN
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
- 2019DACTINOMYCINGeneric (ANDA)
ANDA 203999 · XGEN PHARMS
- 2017DACTINOMYCINGeneric (ANDA)
ANDA 203385 · EUGIA PHARMA
- 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.
