Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215179

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PEMETREXED (PEMETREXED DISODIUM)
EQ 100MG/10ML BASE (10MG/ML)
Marketing Status: Prescription

Active Ingredient: PEMETREXED DISODIUM
Proprietary Name: PEMETREXED
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 100MG/10ML BASE (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215179
Product Number: 001
Approval Date: May 22, 2023
Applicant Holder Full Name: SHILPA MEDICARE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PEMETREXED (PEMETREXED DISODIUM)
EQ 500MG/50ML BASE (10MG/ML)
Marketing Status: Prescription

Active Ingredient: PEMETREXED DISODIUM
Proprietary Name: PEMETREXED
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 500MG/50ML BASE (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215179
Product Number: 002
Approval Date: May 22, 2023
Applicant Holder Full Name: SHILPA MEDICARE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PEMETREXED (PEMETREXED DISODIUM)
EQ 1GM/100ML BASE (10MG/ML)
Marketing Status: Prescription

Active Ingredient: PEMETREXED DISODIUM
Proprietary Name: PEMETREXED
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 1GM/100ML BASE (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215179
Product Number: 003
Approval Date: May 22, 2023
Applicant Holder Full Name: SHILPA MEDICARE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information