Product Details for ANDA 076747
ROSIGLITAZONE MALEATE (ROSIGLITAZONE MALEATE)
EQ 2MG BASE
Marketing Status: Discontinued
EQ 4MG BASE
Marketing Status: Discontinued
EQ 8MG BASE
Marketing Status: Discontinued
EQ 2MG BASE
Marketing Status: Discontinued
Active Ingredient: ROSIGLITAZONE MALEATE
Proprietary Name: ROSIGLITAZONE MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076747
Product Number: 001
Approval Date: Jan 25, 2013
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ROSIGLITAZONE MALEATE (ROSIGLITAZONE MALEATE)
Proprietary Name: ROSIGLITAZONE MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076747
Product Number: 001
Approval Date: Jan 25, 2013
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 4MG BASE
Marketing Status: Discontinued
Active Ingredient: ROSIGLITAZONE MALEATE
Proprietary Name: ROSIGLITAZONE MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076747
Product Number: 002
Approval Date: Jan 25, 2013
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ROSIGLITAZONE MALEATE (ROSIGLITAZONE MALEATE)
Proprietary Name: ROSIGLITAZONE MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076747
Product Number: 002
Approval Date: Jan 25, 2013
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 8MG BASE
Marketing Status: Discontinued
Active Ingredient: ROSIGLITAZONE MALEATE
Proprietary Name: ROSIGLITAZONE MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 8MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076747
Product Number: 003
Approval Date: Jan 25, 2013
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ROSIGLITAZONE MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 8MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076747
Product Number: 003
Approval Date: Jan 25, 2013
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information