Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078709

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ROSIGLITAZONE MALEATE AND GLIMEPIRIDE (GLIMEPIRIDE; ROSIGLITAZONE MALEATE)
1MG;4MG
Marketing Status: Discontinued

Active Ingredient: GLIMEPIRIDE; ROSIGLITAZONE MALEATE
Proprietary Name: ROSIGLITAZONE MALEATE AND GLIMEPIRIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG;4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078709
Product Number: 001
Approval Date: Apr 1, 2016
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information

ROSIGLITAZONE MALEATE AND GLIMEPIRIDE (GLIMEPIRIDE; ROSIGLITAZONE MALEATE)
2MG;4MG
Marketing Status: Discontinued

Active Ingredient: GLIMEPIRIDE; ROSIGLITAZONE MALEATE
Proprietary Name: ROSIGLITAZONE MALEATE AND GLIMEPIRIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG;4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078709
Product Number: 002
Approval Date: Apr 1, 2016
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information

ROSIGLITAZONE MALEATE AND GLIMEPIRIDE (GLIMEPIRIDE; ROSIGLITAZONE MALEATE)
2MG;8MG
Marketing Status: Discontinued

Active Ingredient: GLIMEPIRIDE; ROSIGLITAZONE MALEATE
Proprietary Name: ROSIGLITAZONE MALEATE AND GLIMEPIRIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG;8MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078709
Product Number: 004
Approval Date: Apr 1, 2016
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information

ROSIGLITAZONE MALEATE AND GLIMEPIRIDE (GLIMEPIRIDE; ROSIGLITAZONE MALEATE)
4MG;4MG
Marketing Status: Discontinued

Active Ingredient: GLIMEPIRIDE; ROSIGLITAZONE MALEATE
Proprietary Name: ROSIGLITAZONE MALEATE AND GLIMEPIRIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG;4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078709
Product Number: 003
Approval Date: Apr 1, 2016
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information

ROSIGLITAZONE MALEATE AND GLIMEPIRIDE (GLIMEPIRIDE; ROSIGLITAZONE MALEATE)
4MG;8MG
Marketing Status: Discontinued

Active Ingredient: GLIMEPIRIDE; ROSIGLITAZONE MALEATE
Proprietary Name: ROSIGLITAZONE MALEATE AND GLIMEPIRIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG;8MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078709
Product Number: 005
Approval Date: Apr 1, 2016
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information