Product Details for ANDA 076685
SIMVASTATIN (SIMVASTATIN)
5MG
Marketing Status: Discontinued
10MG
Marketing Status: Discontinued
20MG
Marketing Status: Discontinued
40MG
Marketing Status: Discontinued
80MG
Marketing Status: Discontinued
5MG
Marketing Status: Discontinued
Active Ingredient: SIMVASTATIN
Proprietary Name: SIMVASTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076685
Product Number: 001
Approval Date: Dec 20, 2006
Applicant Holder Full Name: WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
SIMVASTATIN (SIMVASTATIN)
Proprietary Name: SIMVASTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076685
Product Number: 001
Approval Date: Dec 20, 2006
Applicant Holder Full Name: WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG
Marketing Status: Discontinued
Active Ingredient: SIMVASTATIN
Proprietary Name: SIMVASTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076685
Product Number: 002
Approval Date: Dec 20, 2006
Applicant Holder Full Name: WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
SIMVASTATIN (SIMVASTATIN)
Proprietary Name: SIMVASTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076685
Product Number: 002
Approval Date: Dec 20, 2006
Applicant Holder Full Name: WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
20MG
Marketing Status: Discontinued
Active Ingredient: SIMVASTATIN
Proprietary Name: SIMVASTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076685
Product Number: 003
Approval Date: Dec 20, 2006
Applicant Holder Full Name: WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
SIMVASTATIN (SIMVASTATIN)
Proprietary Name: SIMVASTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076685
Product Number: 003
Approval Date: Dec 20, 2006
Applicant Holder Full Name: WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
40MG
Marketing Status: Discontinued
Active Ingredient: SIMVASTATIN
Proprietary Name: SIMVASTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076685
Product Number: 004
Approval Date: Dec 20, 2006
Applicant Holder Full Name: WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
SIMVASTATIN (SIMVASTATIN)
Proprietary Name: SIMVASTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076685
Product Number: 004
Approval Date: Dec 20, 2006
Applicant Holder Full Name: WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
80MG
Marketing Status: Discontinued
Active Ingredient: SIMVASTATIN
Proprietary Name: SIMVASTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076685
Product Number: 005
Approval Date: Dec 20, 2006
Applicant Holder Full Name: WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: SIMVASTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076685
Product Number: 005
Approval Date: Dec 20, 2006
Applicant Holder Full Name: WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information