Product Details for ANDA 206557
SIMVASTATIN (SIMVASTATIN)
10MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
40MG
Marketing Status: Prescription
80MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
Active Ingredient: SIMVASTATIN
Proprietary Name: SIMVASTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206557
Product Number: 001
Approval Date: Nov 13, 2017
Applicant Holder Full Name: INVAGEN PHARMACEUTICALS INC
Marketing Status: Prescription
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: AB
Application Number: A206557
Product Number: 001
Approval Date: Nov 13, 2017
Applicant Holder Full Name: INVAGEN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
20MG
Marketing Status: Prescription
Active Ingredient: SIMVASTATIN
Proprietary Name: SIMVASTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206557
Product Number: 002
Approval Date: Nov 13, 2017
Applicant Holder Full Name: INVAGEN PHARMACEUTICALS INC
Marketing Status: Prescription
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: AB
Application Number: A206557
Product Number: 002
Approval Date: Nov 13, 2017
Applicant Holder Full Name: INVAGEN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
40MG
Marketing Status: Prescription
Active Ingredient: SIMVASTATIN
Proprietary Name: SIMVASTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206557
Product Number: 003
Approval Date: Nov 13, 2017
Applicant Holder Full Name: INVAGEN PHARMACEUTICALS INC
Marketing Status: Prescription
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: AB
Application Number: A206557
Product Number: 003
Approval Date: Nov 13, 2017
Applicant Holder Full Name: INVAGEN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
80MG
Marketing Status: Prescription
Active Ingredient: SIMVASTATIN
Proprietary Name: SIMVASTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206557
Product Number: 004
Approval Date: Nov 13, 2017
Applicant Holder Full Name: INVAGEN PHARMACEUTICALS INC
Marketing Status: Prescription
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: AB
Application Number: A206557
Product Number: 004
Approval Date: Nov 13, 2017
Applicant Holder Full Name: INVAGEN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information