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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 022468

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NDA 022468 describes FOLOTYN, which is a drug marketed by Acrotech Biopharma and is included in one NDA. It is available from two suppliers. Additional details are available on the FOLOTYN profile page.

The generic ingredient in FOLOTYN is pralatrexate. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the pralatrexate profile page.

Summary for 022468

Tradename:	FOLOTYN
Applicant:	Acrotech Biopharma
Ingredient:	pralatrexate
Patents:	0

Pharmacology for NDA: 022468

Suppliers and Packaging for NDA: 022468

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468	NDA AUTHORIZED GENERIC	Fresenius Kabi USA, LLC	65219-550	65219-550-01	1 VIAL, SINGLE-DOSE in 1 CARTON (65219-550-01) / 1 mL in 1 VIAL, SINGLE-DOSE
FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468	NDA AUTHORIZED GENERIC	Fresenius Kabi USA, LLC	65219-552	65219-552-02	1 VIAL, SINGLE-DOSE in 1 CARTON (65219-552-02) / 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	20MG/ML (20MG/ML)
Approval Date:	Sep 24, 2009	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	40MG/2ML (20MG/ML)
Approval Date:	Sep 24, 2009	TE:	AP	RLD:	Yes

Expired US Patents for NDA 022468

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009	⤷ Get Started Free	⤷ Get Started Free
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009	⤷ Get Started Free	⤷ Get Started Free
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009	⤷ Get Started Free	⤷ Get Started Free
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009	⤷ Get Started Free	⤷ Get Started Free
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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