An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 203774
Company: APOTEX

Products on ANDA 203774

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203774

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/25/2022	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/29/2024	SUPPL-3	Labeling-Patient Package Insert		Label is not available on this site.
02/29/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
02/29/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203774

PEMETREXED DISODIUM

POWDER;INTRAVENOUS; EQ 100MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALIMTA	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	021462	LILLY
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	203485	ACCORD HLTHCARE
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	203774	APOTEX
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	202596	DR REDDYS
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	214632	EUGIA PHARMA
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	090384	FRESENIUS KABI USA
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	215460	HETERO LABS LTD VI
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	208696	JIANGSU HANSOH PHARM
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	215479	MEITHEAL
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	207352	NANG KUANG PHARM CO
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	216582	PRINSTON INC
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	204890	QILU PHARM HAINAN
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	211899	RELIANCE LIFE
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	214073	ZYDUS PHARMS

POWDER;INTRAVENOUS; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALIMTA	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	021462	LILLY
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	203485	ACCORD HLTHCARE
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	203774	APOTEX
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	202596	DR REDDYS
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	214632	EUGIA PHARMA
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	090384	FRESENIUS KABI USA
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	215460	HETERO LABS LTD VI
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	208696	JIANGSU HANSOH PHARM
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	215479	MEITHEAL
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	207352	NANG KUANG PHARM CO
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	204890	QILU PHARM HAINAN
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	211899	RELIANCE LIFE
PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	214073	ZYDUS PHARMS

Top