Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Product Details for NDA 021700

AVANDARYL (GLIMEPIRIDE; ROSIGLITAZONE MALEATE)
1MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued

Active Ingredient: GLIMEPIRIDE; ROSIGLITAZONE MALEATE
Proprietary Name: AVANDARYL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021700
Product Number: 001
Approval Date: Nov 23, 2005
Applicant Holder Full Name: SB PHARMCO PUERTO RICO INC
Marketing Status: Discontinued
Patent and Exclusivity Information

AVANDARYL (GLIMEPIRIDE; ROSIGLITAZONE MALEATE)
2MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued

Active Ingredient: GLIMEPIRIDE; ROSIGLITAZONE MALEATE
Proprietary Name: AVANDARYL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021700
Product Number: 002
Approval Date: Nov 23, 2005
Applicant Holder Full Name: SB PHARMCO PUERTO RICO INC
Marketing Status: Discontinued
Patent and Exclusivity Information

AVANDARYL (GLIMEPIRIDE; ROSIGLITAZONE MALEATE)
2MG;8MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued

Active Ingredient: GLIMEPIRIDE; ROSIGLITAZONE MALEATE
Proprietary Name: AVANDARYL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG;8MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021700
Product Number: 004
Approval Date: Mar 30, 2007
Applicant Holder Full Name: SB PHARMCO PUERTO RICO INC
Marketing Status: Discontinued
Patent and Exclusivity Information

AVANDARYL (GLIMEPIRIDE; ROSIGLITAZONE MALEATE)
4MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued

Active Ingredient: GLIMEPIRIDE; ROSIGLITAZONE MALEATE
Proprietary Name: AVANDARYL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021700
Product Number: 003
Approval Date: Nov 23, 2005
Applicant Holder Full Name: SB PHARMCO PUERTO RICO INC
Marketing Status: Discontinued
Patent and Exclusivity Information

AVANDARYL (GLIMEPIRIDE; ROSIGLITAZONE MALEATE)
4MG;8MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued

Active Ingredient: GLIMEPIRIDE; ROSIGLITAZONE MALEATE
Proprietary Name: AVANDARYL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG;8MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021700
Product Number: 005
Approval Date: Mar 30, 2007
Applicant Holder Full Name: SB PHARMCO PUERTO RICO INC
Marketing Status: Discontinued
Patent and Exclusivity Information