Details for New Drug Application (NDA): 021462

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NDA 021462 describes ALIMTA, which is a drug marketed by Lilly and is included in one NDA. It is available from one supplier. Additional details are available on the ALIMTA profile page.

The generic ingredient in ALIMTA is pemetrexed disodium. There are twenty-nine drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the pemetrexed disodium profile page.

Summary for 021462

Tradename:	ALIMTA
Applicant:	Lilly
Ingredient:	pemetrexed disodium
Patents:	0

Pharmacology for NDA: 021462

Mechanism of Action	Folic Acid Metabolism Inhibitors

Medical Subject Heading (MeSH) Categories for 021462

Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 021462

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462	NDA	Eli Lilly and Company	0002-7623	0002-7623-01	1 VIAL in 1 CARTON (0002-7623-01) / 20 mL in 1 VIAL
ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462	NDA	Eli Lilly and Company	0002-7640	0002-7640-01	1 VIAL in 1 CARTON (0002-7640-01) / 4 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 500MG BASE/VIAL
Approval Date:	Feb 4, 2004	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 100MG BASE/VIAL
Approval Date:	Sep 7, 2007	TE:	AP	RLD:	Yes

Expired US Patents for NDA 021462

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004	⤷ Get Started Free	⤷ Get Started Free
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-002	Sep 7, 2007	⤷ Get Started Free	⤷ Get Started Free
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004	⤷ Get Started Free	⤷ Get Started Free
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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