Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040385

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TREXALL (METHOTREXATE SODIUM)
EQ 5MG BASE
Marketing Status: Prescription

Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: TREXALL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A040385
Product Number: 001
Approval Date: Mar 21, 2001
Applicant Holder Full Name: BARR LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TREXALL (METHOTREXATE SODIUM)
EQ 7.5MG BASE
Marketing Status: Prescription

Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: TREXALL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 7.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A040385
Product Number: 002
Approval Date: Mar 21, 2001
Applicant Holder Full Name: BARR LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TREXALL (METHOTREXATE SODIUM)
EQ 10MG BASE
Marketing Status: Prescription

Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: TREXALL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A040385
Product Number: 003
Approval Date: Mar 21, 2001
Applicant Holder Full Name: BARR LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TREXALL (METHOTREXATE SODIUM)
EQ 15MG BASE
Marketing Status: Prescription

Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: TREXALL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 15MG BASE
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A040385
Product Number: 004
Approval Date: Mar 21, 2001
Applicant Holder Full Name: BARR LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information