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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021700

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AVANDARYL (GLIMEPIRIDE; ROSIGLITAZONE MALEATE)
1MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: 1MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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2MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: 2MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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2MG;8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: 2MG;8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 effectiveness 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 effectiveness 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 effectiveness 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 effectiveness 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
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