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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 215479

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PEMETREXED DISODIUM (PEMETREXED DISODIUM)
EQ 100MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: PEMETREXED DISODIUM
Proprietary Name: PEMETREXED DISODIUM
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 100MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215479
Product Number: 001
Approval Date: Dec 13, 2022
Applicant Holder Full Name: MEITHEAL PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PEMETREXED DISODIUM (PEMETREXED DISODIUM)
EQ 500MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: PEMETREXED DISODIUM
Proprietary Name: PEMETREXED DISODIUM
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 500MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215479
Product Number: 002
Approval Date: Dec 13, 2022
Applicant Holder Full Name: MEITHEAL PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PEMETREXED DISODIUM (PEMETREXED DISODIUM)
EQ 750MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: PEMETREXED DISODIUM
Proprietary Name: PEMETREXED DISODIUM
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 750MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215479
Product Number: 003
Approval Date: Dec 13, 2022
Applicant Holder Full Name: MEITHEAL PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PEMETREXED DISODIUM (PEMETREXED DISODIUM)
EQ 1GM BASE/VIAL
Marketing Status: Prescription
Active Ingredient: PEMETREXED DISODIUM
Proprietary Name: PEMETREXED DISODIUM
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 1GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215479
Product Number: 004
Approval Date: Dec 13, 2022
Applicant Holder Full Name: MEITHEAL PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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