Orange Book product · Generic (ANDA)
TEMSIROLIMUS
TEMSIROLIMUS
Generic (ANDA)ANDA 207383TE APRX GLAND
At a glance
Aug 16, 2019
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 16, 2019
6 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
TEMSIROLIMUS
Strength
25MG/ML (25MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
ANDA 207383
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.
