Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040843

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METHOTREXATE SODIUM PRESERVATIVE FREE (METHOTREXATE SODIUM)
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: METHOTREXATE SODIUM PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A040843
Product Number: 002
Approval Date: Jan 11, 2010
Applicant Holder Full Name: PHARMACHEMIE BV
Marketing Status:  Prescription
Patent and Exclusivity Information

METHOTREXATE SODIUM PRESERVATIVE FREE (METHOTREXATE SODIUM)
EQ 100MG BASE/4ML (EQ 25MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: METHOTREXATE SODIUM PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 100MG BASE/4ML (EQ 25MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A040843
Product Number: 003
Approval Date: Feb 27, 2012
Applicant Holder Full Name: PHARMACHEMIE BV
Marketing Status:  Prescription
Patent and Exclusivity Information

METHOTREXATE SODIUM PRESERVATIVE FREE (METHOTREXATE SODIUM)
EQ 250MG BASE/10ML (EQ 25MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: METHOTREXATE SODIUM PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 250MG BASE/10ML (EQ 25MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A040843
Product Number: 004
Approval Date: Jan 11, 2010
Applicant Holder Full Name: PHARMACHEMIE BV
Marketing Status:  Prescription
Patent and Exclusivity Information

METHOTREXATE SODIUM PRESERVATIVE FREE (METHOTREXATE SODIUM)
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: METHOTREXATE SODIUM PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A040843
Product Number: 001
Approval Date: Jan 11, 2010
Applicant Holder Full Name: PHARMACHEMIE BV
Marketing Status:  Prescription
Patent and Exclusivity Information