Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076684

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ENOXAPARIN SODIUM (PRESERVATIVE FREE) (ENOXAPARIN SODIUM)
30MG/0.3ML (100MG/ML)
Marketing Status: Prescription

Active Ingredient: ENOXAPARIN SODIUM
Proprietary Name: ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 30MG/0.3ML (100MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A076684
Product Number: 001
Approval Date: Sep 19, 2011
Applicant Holder Full Name: AMPHASTAR PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ENOXAPARIN SODIUM (PRESERVATIVE FREE) (ENOXAPARIN SODIUM)
40MG/0.4ML (100MG/ML)
Marketing Status: Prescription

Active Ingredient: ENOXAPARIN SODIUM
Proprietary Name: ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 40MG/0.4ML (100MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A076684
Product Number: 002
Approval Date: Sep 19, 2011
Applicant Holder Full Name: AMPHASTAR PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ENOXAPARIN SODIUM (PRESERVATIVE FREE) (ENOXAPARIN SODIUM)
60MG/0.6ML (100MG/ML)
Marketing Status: Prescription

Active Ingredient: ENOXAPARIN SODIUM
Proprietary Name: ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 60MG/0.6ML (100MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A076684
Product Number: 003
Approval Date: Sep 19, 2011
Applicant Holder Full Name: AMPHASTAR PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ENOXAPARIN SODIUM (PRESERVATIVE FREE) (ENOXAPARIN SODIUM)
80MG/0.8ML (100MG/ML)
Marketing Status: Prescription

Active Ingredient: ENOXAPARIN SODIUM
Proprietary Name: ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 80MG/0.8ML (100MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A076684
Product Number: 004
Approval Date: Sep 19, 2011
Applicant Holder Full Name: AMPHASTAR PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ENOXAPARIN SODIUM (PRESERVATIVE FREE) (ENOXAPARIN SODIUM)
100MG/ML (100MG/ML)
Marketing Status: Prescription

Active Ingredient: ENOXAPARIN SODIUM
Proprietary Name: ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 100MG/ML (100MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A076684
Product Number: 005
Approval Date: Sep 19, 2011
Applicant Holder Full Name: AMPHASTAR PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ENOXAPARIN SODIUM (PRESERVATIVE FREE) (ENOXAPARIN SODIUM)
120MG/0.8ML (150MG/ML)
Marketing Status: Prescription

Active Ingredient: ENOXAPARIN SODIUM
Proprietary Name: ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 120MG/0.8ML (150MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A076684
Product Number: 006
Approval Date: Sep 19, 2011
Applicant Holder Full Name: AMPHASTAR PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ENOXAPARIN SODIUM (PRESERVATIVE FREE) (ENOXAPARIN SODIUM)
150MG/ML (150MG/ML)
Marketing Status: Prescription

Active Ingredient: ENOXAPARIN SODIUM
Proprietary Name: ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 150MG/ML (150MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A076684
Product Number: 007
Approval Date: Sep 19, 2011
Applicant Holder Full Name: AMPHASTAR PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information