Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205776

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RASUVO (METHOTREXATE)
7.5MG/0.15ML (7.5MG/0.15ML)
Marketing Status: Prescription

Active Ingredient: METHOTREXATE
Proprietary Name: RASUVO
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 7.5MG/0.15ML (7.5MG/0.15ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205776
Product Number: 001
Approval Date: Jul 10, 2014
Applicant Holder Full Name: MEDEXUS PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RASUVO (METHOTREXATE)
10MG/0.20ML (10MG/0.20ML)
Marketing Status: Prescription

Active Ingredient: METHOTREXATE
Proprietary Name: RASUVO
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 10MG/0.20ML (10MG/0.20ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205776
Product Number: 002
Approval Date: Jul 10, 2014
Applicant Holder Full Name: MEDEXUS PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RASUVO (METHOTREXATE)
12.5MG/0.25ML (12.5MG/0.25ML)
Marketing Status: Prescription

Active Ingredient: METHOTREXATE
Proprietary Name: RASUVO
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 12.5MG/0.25ML (12.5MG/0.25ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205776
Product Number: 003
Approval Date: Jul 10, 2014
Applicant Holder Full Name: MEDEXUS PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RASUVO (METHOTREXATE)
15MG/0.30ML (15MG/0.30ML)
Marketing Status: Prescription

Active Ingredient: METHOTREXATE
Proprietary Name: RASUVO
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 15MG/0.30ML (15MG/0.30ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205776
Product Number: 004
Approval Date: Jul 10, 2014
Applicant Holder Full Name: MEDEXUS PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RASUVO (METHOTREXATE)
17.5MG/0.35ML (17.5MG/0.35ML)
Marketing Status: Prescription

Active Ingredient: METHOTREXATE
Proprietary Name: RASUVO
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 17.5MG/0.35ML (17.5MG/0.35ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205776
Product Number: 005
Approval Date: Jul 10, 2014
Applicant Holder Full Name: MEDEXUS PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RASUVO (METHOTREXATE)
20MG/0.4ML (20MG/0.4ML)
Marketing Status: Prescription

Active Ingredient: METHOTREXATE
Proprietary Name: RASUVO
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 20MG/0.4ML (20MG/0.4ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205776
Product Number: 006
Approval Date: Jul 10, 2014
Applicant Holder Full Name: MEDEXUS PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RASUVO (METHOTREXATE)
22.5MG/0.45ML (22.5MG/0.45ML)
Marketing Status: Prescription

Active Ingredient: METHOTREXATE
Proprietary Name: RASUVO
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 22.5MG/0.45ML (22.5MG/0.45ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205776
Product Number: 007
Approval Date: Jul 10, 2014
Applicant Holder Full Name: MEDEXUS PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RASUVO (METHOTREXATE)
25MG/0.5ML (25MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: METHOTREXATE
Proprietary Name: RASUVO
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 25MG/0.5ML (25MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205776
Product Number: 008
Approval Date: Jul 10, 2014
Applicant Holder Full Name: MEDEXUS PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RASUVO (METHOTREXATE)
30MG/0.6ML (30MG/0.6ML)
Marketing Status: Prescription

Active Ingredient: METHOTREXATE
Proprietary Name: RASUVO
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 30MG/0.6ML (30MG/0.6ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205776
Product Number: 010
Approval Date: Jul 10, 2014
Applicant Holder Full Name: MEDEXUS PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RASUVO (METHOTREXATE)
27.5MG/0.55ML (27.5MG/0.55ML)
Marketing Status: Discontinued

Active Ingredient: METHOTREXATE
Proprietary Name: RASUVO
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 27.5MG/0.55ML (27.5MG/0.55ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205776
Product Number: 009
Approval Date: Jul 10, 2014
Applicant Holder Full Name: MEDEXUS PHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information