Orange Book product · Brand (NDA)
FOLOTYN
PRALATREXATE
Brand (NDA)NDA 022468TE APRX ACROTECH BIOPHARMA
At a glance
Sep 24, 2009
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 24, 2009
17 yr ago
Today
Pharmaceutical detail
Active ingredient
PRALATREXATE
Strength
20MG/ML (20MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 022468
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
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.
