Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204824

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OTREXUP (METHOTREXATE)
10MG/0.4ML (10MG/0.4ML) Marketing Status: Prescription

Active Ingredient: METHOTREXATE
Proprietary Name: OTREXUP
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 10MG/0.4ML (10MG/0.4ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204824
Product Number: 001
Approval Date: Oct 11, 2013
Applicant Holder Full Name: ANTARES PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OTREXUP (METHOTREXATE)
12.5MG/0.4ML (12.5MG/0.4ML) Marketing Status: Prescription

Active Ingredient: METHOTREXATE
Proprietary Name: OTREXUP
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 12.5MG/0.4ML (12.5MG/0.4ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204824
Product Number: 006
Approval Date: Mar 24, 2016
Applicant Holder Full Name: ANTARES PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OTREXUP (METHOTREXATE)
15MG/0.4ML (15MG/0.4ML) Marketing Status: Prescription

Active Ingredient: METHOTREXATE
Proprietary Name: OTREXUP
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 15MG/0.4ML (15MG/0.4ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204824
Product Number: 002
Approval Date: Oct 11, 2013
Applicant Holder Full Name: ANTARES PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OTREXUP (METHOTREXATE)
17.5MG/0.4ML (17.5MG/0.4ML) Marketing Status: Prescription

Active Ingredient: METHOTREXATE
Proprietary Name: OTREXUP
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 17.5MG/0.4ML (17.5MG/0.4ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204824
Product Number: 007
Approval Date: Mar 24, 2016
Applicant Holder Full Name: ANTARES PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: METHOTREXATE
Proprietary Name: OTREXUP
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: N204824
Product Number: 003
Approval Date: Oct 11, 2013
Applicant Holder Full Name: ANTARES PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OTREXUP (METHOTREXATE)
22.5MG/0.4ML (22.5MG/0.4ML) Marketing Status: Prescription

Active Ingredient: METHOTREXATE
Proprietary Name: OTREXUP
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 22.5MG/0.4ML (22.5MG/0.4ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204824
Product Number: 008
Approval Date: Mar 24, 2016
Applicant Holder Full Name: ANTARES PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OTREXUP (METHOTREXATE)
25MG/0.4ML (25MG/0.4ML) Marketing Status: Prescription

Active Ingredient: METHOTREXATE
Proprietary Name: OTREXUP
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 25MG/0.4ML (25MG/0.4ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204824
Product Number: 004
Approval Date: Oct 11, 2013
Applicant Holder Full Name: ANTARES PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OTREXUP (METHOTREXATE)
7.5MG/0.4ML (7.5MG/0.4ML) Marketing Status: Discontinued

Active Ingredient: METHOTREXATE
Proprietary Name: OTREXUP
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 7.5MG/0.4ML (7.5MG/0.4ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204824
Product Number: 005
Approval Date: Nov 7, 2014
Applicant Holder Full Name: ANTARES PHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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

Active Ingredient: METHOTREXATE
Proprietary Name: OTREXUP PFS
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: N204824
Product Number: 009
Approval Date: May 31, 2017
Applicant Holder Full Name: ANTARES PHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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

Active Ingredient: METHOTREXATE
Proprietary Name: OTREXUP PFS
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: N204824
Product Number: 010
Approval Date: May 31, 2017
Applicant Holder Full Name: ANTARES PHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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

Active Ingredient: METHOTREXATE
Proprietary Name: OTREXUP PFS
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: N204824
Product Number: 011
Approval Date: May 31, 2017
Applicant Holder Full Name: ANTARES PHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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

Active Ingredient: METHOTREXATE
Proprietary Name: OTREXUP PFS
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: N204824
Product Number: 012
Approval Date: May 31, 2017
Applicant Holder Full Name: ANTARES PHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

OTREXUP PFS (METHOTREXATE)
22.5MG/0.9ML (22.5MG/0.9ML) Marketing Status: Discontinued

Active Ingredient: METHOTREXATE
Proprietary Name: OTREXUP PFS
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 22.5MG/0.9ML (22.5MG/0.9ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204824
Product Number: 013
Approval Date: May 31, 2017
Applicant Holder Full Name: ANTARES PHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

OTREXUP PFS (METHOTREXATE)
25MG/ML (25MG/ML) Marketing Status: Discontinued

Active Ingredient: METHOTREXATE
Proprietary Name: OTREXUP PFS
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 25MG/ML (25MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204824
Product Number: 014
Approval Date: May 31, 2017
Applicant Holder Full Name: ANTARES PHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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