Orange Book product · Brand (NDA)
PEMETREXED DISODIUM
PEMETREXED DISODIUM
At a glance
May 26, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 26, 2022
4 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
PEMETREXED DISODIUM
Strength
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 214657
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.
- 2023PEMETREXEDBrand (NDA)
NDA 215179 · SHILPA
- 2022PEMETREXED DISODIUMBrand (NDA)
NDA 214408 · ACCORD HLTHCARE
- 2022PEMETREXED DISODIUMBrand (NDA)
NDA 214218 · HOSPIRA
- 2007ALIMTABrand (NDA)
NDA 021462 · LILLY
- 2024PEMETREXED DISODIUMGeneric (ANDA)
ANDA 215460 · HETERO LABS LTD VI
- 2023PEMETREXED DISODIUMGeneric (ANDA)
ANDA 216582 · PRINSTON INC
- 2023PEMETREXED DISODIUMGeneric (ANDA)
ANDA 210047 · AMNEAL
- 2023PEMETREXED DISODIUMGeneric (ANDA)
ANDA 203628 · PHARMOBEDIENT
- 2022PEMETREXED DISODIUMGeneric (ANDA)
ANDA 215479 · MEITHEAL
- 2022PEMETREXED DISODIUMGeneric (ANDA)
ANDA 214436 · BAXTER HLTHCARE CORP
- 2022PEMETREXED DISODIUMGeneric (ANDA)
ANDA 203485 · ACCORD HLTHCARE
- 2022PEMETREXED DISODIUMGeneric (ANDA)
ANDA 209085 · APOTEX
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.
