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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214408

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PEMETREXED DISODIUM (PEMETREXED DISODIUM)
EQ 100MG BASE/4ML (EQ 25MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: PEMETREXED DISODIUM
Proprietary Name: PEMETREXED DISODIUM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 100MG BASE/4ML (EQ 25MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214408
Product Number: 001
Approval Date: Jul 19, 2022
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PEMETREXED DISODIUM (PEMETREXED DISODIUM)
EQ 500MG BASE/20ML (EQ 25MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: PEMETREXED DISODIUM
Proprietary Name: PEMETREXED DISODIUM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 500MG BASE/20ML (EQ 25MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214408
Product Number: 002
Approval Date: Jul 19, 2022
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PEMETREXED DISODIUM (PEMETREXED DISODIUM)
EQ 850MG BASE/34ML (EQ 25MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: PEMETREXED DISODIUM
Proprietary Name: PEMETREXED DISODIUM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 850MG BASE/34ML (EQ 25MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214408
Product Number: 003
Approval Date: Jul 19, 2022
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PEMETREXED DISODIUM (PEMETREXED DISODIUM)
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: PEMETREXED DISODIUM
Proprietary Name: PEMETREXED DISODIUM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214408
Product Number: 004
Approval Date: Jul 19, 2022
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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