Product Details for ANDA 076745
OXYBUTYNIN CHLORIDE (OXYBUTYNIN CHLORIDE)
5MG
Marketing Status: Discontinued
10MG
Marketing Status: Discontinued
15MG
Marketing Status: Discontinued
5MG
Marketing Status: Discontinued
Active Ingredient: OXYBUTYNIN CHLORIDE
Proprietary Name: OXYBUTYNIN CHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076745
Product Number: 002
Approval Date: May 9, 2007
Applicant Holder Full Name: IMPAX PHARMACEUTICALS
Marketing Status: Discontinued
Patent and Exclusivity Information
OXYBUTYNIN CHLORIDE (OXYBUTYNIN CHLORIDE)
Proprietary Name: OXYBUTYNIN CHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076745
Product Number: 002
Approval Date: May 9, 2007
Applicant Holder Full Name: IMPAX PHARMACEUTICALS
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG
Marketing Status: Discontinued
Active Ingredient: OXYBUTYNIN CHLORIDE
Proprietary Name: OXYBUTYNIN CHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076745
Product Number: 003
Approval Date: May 9, 2007
Applicant Holder Full Name: IMPAX PHARMACEUTICALS
Marketing Status: Discontinued
Patent and Exclusivity Information
OXYBUTYNIN CHLORIDE (OXYBUTYNIN CHLORIDE)
Proprietary Name: OXYBUTYNIN CHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076745
Product Number: 003
Approval Date: May 9, 2007
Applicant Holder Full Name: IMPAX PHARMACEUTICALS
Marketing Status: Discontinued
Patent and Exclusivity Information
15MG
Marketing Status: Discontinued
Active Ingredient: OXYBUTYNIN CHLORIDE
Proprietary Name: OXYBUTYNIN CHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076745
Product Number: 001
Approval Date: Nov 9, 2006
Applicant Holder Full Name: IMPAX PHARMACEUTICALS
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: OXYBUTYNIN CHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076745
Product Number: 001
Approval Date: Nov 9, 2006
Applicant Holder Full Name: IMPAX PHARMACEUTICALS
Marketing Status: Discontinued
Patent and Exclusivity Information