Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021629

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APIDRA (INSULIN GLULISINE RECOMBINANT)
1000 UNITS/10ML (100 UNITS/ML) Marketing Status: Prescription

Active Ingredient: INSULIN GLULISINE RECOMBINANT
Proprietary Name: APIDRA
Dosage Form; Route of Administration: INJECTABLE; IV (INFUSION), SUBCUTANEOUS
Strength: 1000 UNITS/10ML (100 UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021629
Product Number: 001
Approval Date: Apr 16, 2004
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

APIDRA (INSULIN GLULISINE RECOMBINANT)
300 UNITS/3ML (100 UNITS/ML) Marketing Status: Prescription

Active Ingredient: INSULIN GLULISINE RECOMBINANT
Proprietary Name: APIDRA
Dosage Form; Route of Administration: INJECTABLE; IV (INFUSION), SUBCUTANEOUS
Strength: 300 UNITS/3ML (100 UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021629
Product Number: 002
Approval Date: Dec 20, 2005
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

APIDRA SOLOSTAR (INSULIN GLULISINE RECOMBINANT)
300 UNITS/3ML Marketing Status: Prescription

Active Ingredient: INSULIN GLULISINE RECOMBINANT
Proprietary Name: APIDRA SOLOSTAR
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 300 UNITS/3ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021629
Product Number: 003
Approval Date: Feb 24, 2009
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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