Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020622

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COPAXONE (GLATIRAMER ACETATE)
20MG/ML
Marketing Status: Prescription

Active Ingredient: GLATIRAMER ACETATE
Proprietary Name: COPAXONE
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 20MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N020622
Product Number: 002
Approval Date: Feb 12, 2002
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

COPAXONE (GLATIRAMER ACETATE)
40MG/ML
Marketing Status: Prescription

Active Ingredient: GLATIRAMER ACETATE
Proprietary Name: COPAXONE
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 40MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N020622
Product Number: 003
Approval Date: Jan 28, 2014
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

COPAXONE (GLATIRAMER ACETATE)
20MG/VIAL
Marketing Status: Discontinued

Active Ingredient: GLATIRAMER ACETATE
Proprietary Name: COPAXONE
Dosage Form; Route of Administration: FOR SOLUTION; SUBCUTANEOUS
Strength: 20MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020622
Product Number: 001
Approval Date: Dec 20, 1996
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information