Product Details for ANDA 076908
RISPERIDONE (RISPERIDONE)
0.5MG
Marketing Status: Discontinued
1MG
Marketing Status: Discontinued
2MG
Marketing Status: Discontinued
0.5MG
Marketing Status: Discontinued
Active Ingredient: RISPERIDONE
Proprietary Name: RISPERIDONE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076908
Product Number: 001
Approval Date: Mar 12, 2012
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
RISPERIDONE (RISPERIDONE)
Proprietary Name: RISPERIDONE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076908
Product Number: 001
Approval Date: Mar 12, 2012
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
1MG
Marketing Status: Discontinued
Active Ingredient: RISPERIDONE
Proprietary Name: RISPERIDONE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076908
Product Number: 002
Approval Date: Mar 12, 2012
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
RISPERIDONE (RISPERIDONE)
Proprietary Name: RISPERIDONE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076908
Product Number: 002
Approval Date: Mar 12, 2012
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
2MG
Marketing Status: Discontinued
Active Ingredient: RISPERIDONE
Proprietary Name: RISPERIDONE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076908
Product Number: 003
Approval Date: Mar 12, 2012
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: RISPERIDONE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076908
Product Number: 003
Approval Date: Mar 12, 2012
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information