Product Details for NDA 021071
AVANDIA (ROSIGLITAZONE MALEATE)
EQ 2MG BASE
Marketing Status: Discontinued
EQ 4MG BASE
Marketing Status: Discontinued
EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 2MG BASE
Marketing Status: Discontinued
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: WOODWARD PHARMA SERVICES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
AVANDIA (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: WOODWARD PHARMA SERVICES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 4MG BASE
Marketing Status: Discontinued
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: WOODWARD PHARMA SERVICES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
AVANDIA (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: WOODWARD PHARMA SERVICES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: WOODWARD PHARMA SERVICES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
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 effectiveness 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: WOODWARD PHARMA SERVICES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information