Product Details for NDA 019766
ZOCOR (SIMVASTATIN)
5MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
40MG
Marketing Status: Prescription
80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
5MG
Marketing Status: Prescription
Active Ingredient: SIMVASTATIN
Proprietary Name: ZOCOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019766
Product Number: 001
Approval Date: Dec 23, 1991
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status: Prescription
Patent and Exclusivity Information
ZOCOR (SIMVASTATIN)
Proprietary Name: ZOCOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019766
Product Number: 001
Approval Date: Dec 23, 1991
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status: Prescription
Patent and Exclusivity Information
10MG
Marketing Status: Prescription
Active Ingredient: SIMVASTATIN
Proprietary Name: ZOCOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019766
Product Number: 002
Approval Date: Dec 23, 1991
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status: Prescription
Patent and Exclusivity Information
ZOCOR (SIMVASTATIN)
Proprietary Name: ZOCOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019766
Product Number: 002
Approval Date: Dec 23, 1991
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status: Prescription
Patent and Exclusivity Information
20MG
Marketing Status: Prescription
Active Ingredient: SIMVASTATIN
Proprietary Name: ZOCOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019766
Product Number: 003
Approval Date: Dec 23, 1991
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status: Prescription
Patent and Exclusivity Information
ZOCOR (SIMVASTATIN)
Proprietary Name: ZOCOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019766
Product Number: 003
Approval Date: Dec 23, 1991
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status: Prescription
Patent and Exclusivity Information
40MG
Marketing Status: Prescription
Active Ingredient: SIMVASTATIN
Proprietary Name: ZOCOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019766
Product Number: 004
Approval Date: Dec 23, 1991
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status: Prescription
Patent and Exclusivity Information
ZOCOR (SIMVASTATIN)
Proprietary Name: ZOCOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019766
Product Number: 004
Approval Date: Dec 23, 1991
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status: Prescription
Patent and Exclusivity Information
80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: SIMVASTATIN
Proprietary Name: ZOCOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019766
Product Number: 005
Approval Date: Jul 10, 1998
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ZOCOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019766
Product Number: 005
Approval Date: Jul 10, 1998
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status: Discontinued
Patent and Exclusivity Information