Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021172

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NOVOLOG MIX 70/30 (INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT)
700 UNITS/10ML; 300 UNITS/10ML (70 UNITS/ML; 30 UNITS/ML) Marketing Status: Prescription

Active Ingredient: INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT
Proprietary Name: NOVOLOG MIX 70/30
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 700 UNITS/10ML; 300 UNITS/10ML (70 UNITS/ML; 30 UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021172
Product Number: 001
Approval Date: Nov 1, 2001
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NOVOLOG MIX 70/30 FLEXPEN (INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT)
210 UNITS/3ML; 90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML) Marketing Status: Prescription

Active Ingredient: INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT
Proprietary Name: NOVOLOG MIX 70/30 FLEXPEN
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 210 UNITS/3ML; 90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021172
Product Number: 004
Approval Date: May 3, 2002
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NOVOLOG MIX 70/30 PENFILL (INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT)
210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML) Marketing Status: Discontinued

Active Ingredient: INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT
Proprietary Name: NOVOLOG MIX 70/30 PENFILL
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021172
Product Number: 002
Approval Date: Nov 1, 2001
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

NOVOLOG MIX 70/30 PENFILL (INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT)
210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML) Marketing Status: Discontinued

Active Ingredient: INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT
Proprietary Name: NOVOLOG MIX 70/30 PENFILL
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021172
Product Number: 003
Approval Date: Nov 1, 2001
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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