Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020986

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NOVOLOG (INSULIN ASPART RECOMBINANT)
1000 UNITS/10ML (100 UNITS/ML) Marketing Status: Prescription

Active Ingredient: INSULIN ASPART RECOMBINANT
Proprietary Name: NOVOLOG
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 1000 UNITS/10ML (100 UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020986
Product Number: 001
Approval Date: Jun 7, 2000
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NOVOLOG FLEXPEN (INSULIN ASPART RECOMBINANT)
300 UNITS/3ML (100 UNITS/ML) Marketing Status: Prescription

Active Ingredient: INSULIN ASPART RECOMBINANT
Proprietary Name: NOVOLOG FLEXPEN
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 300 UNITS/3ML (100 UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020986
Product Number: 003
Approval Date: Jan 19, 2001
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NOVOLOG FLEXTOUCH (INSULIN ASPART RECOMBINANT)
300 UNITS/3ML (100 UNITS/ML) Marketing Status: Prescription

Active Ingredient: INSULIN ASPART RECOMBINANT
Proprietary Name: NOVOLOG FLEXTOUCH
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 300 UNITS/3ML (100 UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020986
Product Number: 005
Approval Date: Oct 31, 2013
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NOVOLOG PENFILL (INSULIN ASPART RECOMBINANT)
300 UNITS/3ML (100 UNITS/ML) Marketing Status: Prescription

Active Ingredient: INSULIN ASPART RECOMBINANT
Proprietary Name: NOVOLOG PENFILL
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 300 UNITS/3ML (100 UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020986
Product Number: 002
Approval Date: Jun 7, 2000
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NOVOLOG INNOLET (INSULIN ASPART RECOMBINANT)
300 UNITS/3ML (100 UNITS/ML) Marketing Status: Discontinued

Active Ingredient: INSULIN ASPART RECOMBINANT
Proprietary Name: NOVOLOG INNOLET
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 300 UNITS/3ML (100 UNITS/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020986
Product Number: 004
Approval Date: Apr 23, 2004
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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