Orange Book product · Generic (ANDA)
TEMSIROLIMUS
TEMSIROLIMUS
Generic (ANDA)ANDA 203153TE APRX ACCORD HLTHCARE
At a glance
Jul 30, 2018
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 30, 2018
8 yr ago
Today
Pharmaceutical detail
Active ingredient
TEMSIROLIMUS
Strength
25MG/ML (25MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
ANDA 203153
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TEMSIROLIMUS
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.
