Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210737

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REDITREX (METHOTREXATE)
7.5MG/0.3ML (7.5MG/0.3ML)
Marketing Status: Discontinued

Active Ingredient: METHOTREXATE
Proprietary Name: REDITREX
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 7.5MG/0.3ML (7.5MG/0.3ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210737
Product Number: 001
Approval Date: Nov 27, 2019
Applicant Holder Full Name: NORDIC GROUP BV
Marketing Status:  Discontinued
Patent and Exclusivity Information

REDITREX (METHOTREXATE)
10MG/0.4ML (10MG/0.4ML)
Marketing Status: Discontinued

Active Ingredient: METHOTREXATE
Proprietary Name: REDITREX
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 10MG/0.4ML (10MG/0.4ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210737
Product Number: 002
Approval Date: Nov 27, 2019
Applicant Holder Full Name: NORDIC GROUP BV
Marketing Status:  Discontinued
Patent and Exclusivity Information

REDITREX (METHOTREXATE)
12.5MG/0.5ML (12.5MG/0.5ML)
Marketing Status: Discontinued

Active Ingredient: METHOTREXATE
Proprietary Name: REDITREX
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 12.5MG/0.5ML (12.5MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210737
Product Number: 003
Approval Date: Nov 27, 2019
Applicant Holder Full Name: NORDIC GROUP BV
Marketing Status:  Discontinued
Patent and Exclusivity Information

REDITREX (METHOTREXATE)
15MG/0.6ML (15MG/0.6ML)
Marketing Status: Discontinued

Active Ingredient: METHOTREXATE
Proprietary Name: REDITREX
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 15MG/0.6ML (15MG/0.6ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210737
Product Number: 004
Approval Date: Nov 27, 2019
Applicant Holder Full Name: NORDIC GROUP BV
Marketing Status:  Discontinued
Patent and Exclusivity Information

REDITREX (METHOTREXATE)
17.5MG/0.7ML (17.5MG/0.7ML)
Marketing Status: Discontinued

Active Ingredient: METHOTREXATE
Proprietary Name: REDITREX
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 17.5MG/0.7ML (17.5MG/0.7ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210737
Product Number: 005
Approval Date: Nov 27, 2019
Applicant Holder Full Name: NORDIC GROUP BV
Marketing Status:  Discontinued
Patent and Exclusivity Information

REDITREX (METHOTREXATE)
20MG/0.8ML (20MG/0.8ML)
Marketing Status: Discontinued

Active Ingredient: METHOTREXATE
Proprietary Name: REDITREX
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 20MG/0.8ML (20MG/0.8ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210737
Product Number: 006
Approval Date: Nov 27, 2019
Applicant Holder Full Name: NORDIC GROUP BV
Marketing Status:  Discontinued
Patent and Exclusivity Information

REDITREX (METHOTREXATE)
22.5MG/ML (22.5MG/ML)
Marketing Status: Discontinued

Active Ingredient: METHOTREXATE
Proprietary Name: REDITREX
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 22.5MG/ML (22.5MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210737
Product Number: 007
Approval Date: Nov 27, 2019
Applicant Holder Full Name: NORDIC GROUP BV
Marketing Status:  Discontinued
Patent and Exclusivity Information

REDITREX (METHOTREXATE)
25MG/1ML (25MG/1ML)
Marketing Status: Discontinued

Active Ingredient: METHOTREXATE
Proprietary Name: REDITREX
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 25MG/1ML (25MG/1ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210737
Product Number: 008
Approval Date: Nov 27, 2019
Applicant Holder Full Name: NORDIC GROUP BV
Marketing Status:  Discontinued
Patent and Exclusivity Information