Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208419

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PEMETREXED (PEMETREXED)
100MG/4ML (25MG/ML)
Marketing Status: Prescription

Active Ingredient: PEMETREXED
Proprietary Name: PEMETREXED
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 100MG/4ML (25MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208419
Product Number: 001
Approval Date: Aug 21, 2020
Applicant Holder Full Name: ACTAVIS LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PEMETREXED (PEMETREXED)
500MG/20ML (25MG/ML)
Marketing Status: Prescription

Active Ingredient: PEMETREXED
Proprietary Name: PEMETREXED
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 500MG/20ML (25MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208419
Product Number: 002
Approval Date: Aug 21, 2020
Applicant Holder Full Name: ACTAVIS LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PEMETREXED (PEMETREXED)
1GM/40ML (25MG/ML)
Marketing Status: Prescription

Active Ingredient: PEMETREXED
Proprietary Name: PEMETREXED
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1GM/40ML (25MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208419
Product Number: 003
Approval Date: Aug 21, 2020
Applicant Holder Full Name: ACTAVIS LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information