Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021071

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AVANDIA (ROSIGLITAZONE MALEATE)
EQ 2MG BASE
Marketing Status: Prescription
Active Ingredient: ROSIGLITAZONE MALEATE
Proprietary Name: AVANDIA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021071
Product Number: 002
Approval Date: May 25, 1999
Applicant Holder Full Name: SB PHARMCO PUERTO RICO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
AVANDIA (ROSIGLITAZONE MALEATE)
EQ 4MG BASE
Marketing Status: Prescription
Active Ingredient: ROSIGLITAZONE MALEATE
Proprietary Name: AVANDIA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021071
Product Number: 003
Approval Date: May 25, 1999
Applicant Holder Full Name: SB PHARMCO PUERTO RICO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
AVANDIA (ROSIGLITAZONE MALEATE)
EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: ROSIGLITAZONE MALEATE
Proprietary Name: AVANDIA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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: N021071
Product Number: 004
Approval Date: May 25, 1999
Applicant Holder Full Name: SB PHARMCO PUERTO RICO INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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