Product Details for NDA 208746
PEMETREXED DITROMETHAMINE (PEMETREXED DITROMETHAMINE)
EQ 100MG BASE/VIAL
Marketing Status: Prescription
EQ 500MG BASE/VIAL
Marketing Status: Prescription
EQ 1GM BASE/VIAL
Marketing Status: Discontinued
EQ 100MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: PEMETREXED DITROMETHAMINE
Proprietary Name: PEMETREXED DITROMETHAMINE
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 100MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N208746
Product Number: 001
Approval Date: Jun 10, 2022
Applicant Holder Full Name: HOSPIRA INC
Marketing Status: Prescription
Patent and Exclusivity Information
PEMETREXED DITROMETHAMINE (PEMETREXED DITROMETHAMINE)
Proprietary Name: PEMETREXED DITROMETHAMINE
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 100MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N208746
Product Number: 001
Approval Date: Jun 10, 2022
Applicant Holder Full Name: HOSPIRA INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 500MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: PEMETREXED DITROMETHAMINE
Proprietary Name: PEMETREXED DITROMETHAMINE
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 500MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N208746
Product Number: 002
Approval Date: Jun 10, 2022
Applicant Holder Full Name: HOSPIRA INC
Marketing Status: Prescription
Patent and Exclusivity Information
PEMETREXED DITROMETHAMINE (PEMETREXED DITROMETHAMINE)
Proprietary Name: PEMETREXED DITROMETHAMINE
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 500MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N208746
Product Number: 002
Approval Date: Jun 10, 2022
Applicant Holder Full Name: HOSPIRA INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 1GM BASE/VIAL
Marketing Status: Discontinued
Active Ingredient: PEMETREXED DITROMETHAMINE
Proprietary Name: PEMETREXED DITROMETHAMINE
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 1GM BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N208746
Product Number: 003
Approval Date: Jun 10, 2022
Applicant Holder Full Name: HOSPIRA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PEMETREXED DITROMETHAMINE
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 1GM BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N208746
Product Number: 003
Approval Date: Jun 10, 2022
Applicant Holder Full Name: HOSPIRA INC
Marketing Status: Discontinued
Patent and Exclusivity Information