Orange Book product · Brand (NDA)
PEMETREXED
PEMETREXED
Brand (NDA)NDA 208419RX ACTAVIS
At a glance
Aug 21, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 21, 2020
5 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
PEMETREXED
Strength
1GM/40ML (25MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 208419
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
