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Details for New Drug Application (NDA): 022468

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NDA 022468 describes FOLOTYN, which is a drug marketed by Allos and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. 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. One supplier is listed for this compound. There are two tentative approvals for this compound. Additional details are available on the pralatrexate profile page.

Summary for NDA: 022468

Tradename:
FOLOTYN
Applicant:
Allos
Ingredient:
pralatrexate
Patents:3
Formulation / Manufacturing:see details

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 Allos Therapeutics 48818-001 48818-001-01 1 VIAL, SINGLE-USE in 1 CARTON (48818-001-01) > 1 mL in 1 VIAL, SINGLE-USE
FOLOTYN
pralatrexate
SOLUTION;INTRAVENOUS 022468 NDA Allos Therapeutics 48818-001 48818-001-02 1 VIAL, SINGLE-USE in 1 CARTON (48818-001-02) > 2 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength20MG/ML (20MG/ML)
Approval Date:Sep 24, 2009TE:RLD:No
Regulatory Exclusivity Expiration:Sep 24, 2016
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:6,028,071Patent Expiration:Jul 16, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
Patent:7,622,470Patent Expiration:May 31, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA


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