Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022468

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FOLOTYN (PRALATREXATE)
20MG/ML (20MG/ML)
Marketing Status: Prescription

Active Ingredient: PRALATREXATE
Proprietary Name: FOLOTYN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 20MG/ML (20MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022468
Product Number: 001
Approval Date: Sep 24, 2009
Applicant Holder Full Name: ACROTECH BIOPHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FOLOTYN (PRALATREXATE)
40MG/2ML (20MG/ML)
Marketing Status: Prescription

Active Ingredient: PRALATREXATE
Proprietary Name: FOLOTYN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 40MG/2ML (20MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022468
Product Number: 002
Approval Date: Sep 24, 2009
Applicant Holder Full Name: ACROTECH BIOPHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information