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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020164

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LOVENOX (ENOXAPARIN SODIUM)
300MG/3ML (100MG/ML)
Marketing Status: Prescription
Active Ingredient: ENOXAPARIN SODIUM
Proprietary Name: LOVENOX
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS, SUBCUTANEOUS
Strength: 300MG/3ML (100MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020164
Product Number: 009
Approval Date: Jan 23, 2003
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LOVENOX (PRESERVATIVE FREE) (ENOXAPARIN SODIUM)
30MG/0.3ML (100MG/ML)
Marketing Status: Prescription
Active Ingredient: ENOXAPARIN SODIUM
Proprietary Name: LOVENOX (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 30MG/0.3ML (100MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020164
Product Number: 001
Approval Date: Mar 29, 1993
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LOVENOX (PRESERVATIVE FREE) (ENOXAPARIN SODIUM)
40MG/0.4ML (100MG/ML)
Marketing Status: Prescription
Active Ingredient: ENOXAPARIN SODIUM
Proprietary Name: LOVENOX (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 40MG/0.4ML (100MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020164
Product Number: 002
Approval Date: Jan 30, 1998
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LOVENOX (PRESERVATIVE FREE) (ENOXAPARIN SODIUM)
60MG/0.6ML (100MG/ML)
Marketing Status: Prescription
Active Ingredient: ENOXAPARIN SODIUM
Proprietary Name: LOVENOX (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 60MG/0.6ML (100MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020164
Product Number: 003
Approval Date: Mar 27, 1998
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LOVENOX (PRESERVATIVE FREE) (ENOXAPARIN SODIUM)
80MG/0.8ML (100MG/ML)
Marketing Status: Prescription
Active Ingredient: ENOXAPARIN SODIUM
Proprietary Name: LOVENOX (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 80MG/0.8ML (100MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020164
Product Number: 004
Approval Date: Mar 27, 1998
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LOVENOX (PRESERVATIVE FREE) (ENOXAPARIN SODIUM)
100MG/ML (100MG/ML)
Marketing Status: Prescription
Active Ingredient: ENOXAPARIN SODIUM
Proprietary Name: LOVENOX (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 100MG/ML (100MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N020164
Product Number: 005
Approval Date: Mar 27, 1998
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LOVENOX (PRESERVATIVE FREE) (ENOXAPARIN SODIUM)
120MG/0.8ML (150MG/ML)
Marketing Status: Prescription
Active Ingredient: ENOXAPARIN SODIUM
Proprietary Name: LOVENOX (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 120MG/0.8ML (150MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020164
Product Number: 007
Approval Date: Jun 2, 2000
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LOVENOX (PRESERVATIVE FREE) (ENOXAPARIN SODIUM)
150MG/ML (150MG/ML)
Marketing Status: Prescription
Active Ingredient: ENOXAPARIN SODIUM
Proprietary Name: LOVENOX (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 150MG/ML (150MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020164
Product Number: 008
Approval Date: Jun 2, 2000
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LOVENOX (PRESERVATIVE FREE) (ENOXAPARIN SODIUM)
90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ENOXAPARIN SODIUM
Proprietary Name: LOVENOX (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020164
Product Number: 006
Approval Date: Jun 2, 2000
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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