Product Details for NDA 214657
PEMETREXED DISODIUM (PEMETREXED DISODIUM)
EQ 100MG BASE/4ML (EQ 25MG BASE/ML)
Marketing Status: Prescription
EQ 500MG BASE/20ML (EQ 25MG BASE/ML)
Marketing Status: Prescription
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
Marketing Status: Prescription
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: N214657
Product Number: 001
Approval Date: May 26, 2022
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
PEMETREXED DISODIUM (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: N214657
Product Number: 001
Approval Date: May 26, 2022
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: N214657
Product Number: 002
Approval Date: May 26, 2022
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
PEMETREXED DISODIUM (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: N214657
Product Number: 002
Approval Date: May 26, 2022
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: N214657
Product Number: 003
Approval Date: May 26, 2022
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: N214657
Product Number: 003
Approval Date: May 26, 2022
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information