Product Details for NDA 021316
ALTOPREV (LOVASTATIN)
20MG
Marketing Status: Prescription
40MG
Marketing Status: Prescription
60MG
Marketing Status: Prescription
10MG
Marketing Status: Discontinued
20MG
Marketing Status: Prescription
Active Ingredient: LOVASTATIN
Proprietary Name: ALTOPREV
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021316
Product Number: 002
Approval Date: Jun 26, 2002
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status: Prescription
Patent and Exclusivity Information
ALTOPREV (LOVASTATIN)
Proprietary Name: ALTOPREV
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021316
Product Number: 002
Approval Date: Jun 26, 2002
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status: Prescription
Patent and Exclusivity Information
40MG
Marketing Status: Prescription
Active Ingredient: LOVASTATIN
Proprietary Name: ALTOPREV
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021316
Product Number: 003
Approval Date: Jun 26, 2002
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status: Prescription
Patent and Exclusivity Information
ALTOPREV (LOVASTATIN)
Proprietary Name: ALTOPREV
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021316
Product Number: 003
Approval Date: Jun 26, 2002
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status: Prescription
Patent and Exclusivity Information
60MG
Marketing Status: Prescription
Active Ingredient: LOVASTATIN
Proprietary Name: ALTOPREV
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N021316
Product Number: 004
Approval Date: Jun 26, 2002
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status: Prescription
Patent and Exclusivity Information
ALTOPREV (LOVASTATIN)
Proprietary Name: ALTOPREV
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N021316
Product Number: 004
Approval Date: Jun 26, 2002
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status: Prescription
Patent and Exclusivity Information
10MG
Marketing Status: Discontinued
Active Ingredient: LOVASTATIN
Proprietary Name: ALTOPREV
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N021316
Product Number: 001
Approval Date: Jun 26, 2002
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ALTOPREV
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N021316
Product Number: 001
Approval Date: Jun 26, 2002
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status: Discontinued
Patent and Exclusivity Information