Product Details for ANDA 090384
PEMETREXED DISODIUM (PEMETREXED DISODIUM)
EQ 100MG BASE/VIAL
Marketing Status: Prescription
EQ 500MG BASE/VIAL
Marketing Status: Prescription
EQ 750MG BASE/VIAL
Marketing Status: Prescription
EQ 1GM BASE/VIAL
Marketing Status: Prescription
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: A090384
Product Number: 001
Approval Date: May 25, 2022
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
PEMETREXED DISODIUM (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: A090384
Product Number: 001
Approval Date: May 25, 2022
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
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: A090384
Product Number: 002
Approval Date: May 25, 2022
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
PEMETREXED DISODIUM (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: A090384
Product Number: 002
Approval Date: May 25, 2022
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
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: Yes
TE Code: AP
Application Number: A090384
Product Number: 003
Approval Date: May 25, 2022
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
PEMETREXED DISODIUM (PEMETREXED DISODIUM)
Proprietary Name: PEMETREXED DISODIUM
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 750MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A090384
Product Number: 003
Approval Date: May 25, 2022
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
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: Yes
TE Code: AP
Application Number: A090384
Product Number: 004
Approval Date: May 25, 2022
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: PEMETREXED DISODIUM
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 1GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A090384
Product Number: 004
Approval Date: May 25, 2022
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information