Product Details for ANDA 090383
SIMVASTATIN (SIMVASTATIN)
5MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
40MG
Marketing Status: Prescription
80MG
Marketing Status: Prescription
5MG
Marketing Status: Prescription
Active Ingredient: SIMVASTATIN
Proprietary Name: SIMVASTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090383
Product Number: 001
Approval Date: Sep 16, 2011
Applicant Holder Full Name: MICRO LABS LTD
Marketing Status: Prescription
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: AB
Application Number: A090383
Product Number: 001
Approval Date: Sep 16, 2011
Applicant Holder Full Name: MICRO LABS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A090383
Product Number: 002
Approval Date: Sep 16, 2011
Applicant Holder Full Name: MICRO LABS LTD
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: A090383
Product Number: 002
Approval Date: Sep 16, 2011
Applicant Holder Full Name: MICRO LABS LTD
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: A090383
Product Number: 003
Approval Date: Sep 16, 2011
Applicant Holder Full Name: MICRO LABS LTD
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: A090383
Product Number: 003
Approval Date: Sep 16, 2011
Applicant Holder Full Name: MICRO LABS LTD
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: A090383
Product Number: 004
Approval Date: Sep 16, 2011
Applicant Holder Full Name: MICRO LABS LTD
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: A090383
Product Number: 004
Approval Date: Sep 16, 2011
Applicant Holder Full Name: MICRO LABS LTD
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: A090383
Product Number: 005
Approval Date: Sep 16, 2011
Applicant Holder Full Name: MICRO LABS LTD
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: A090383
Product Number: 005
Approval Date: Sep 16, 2011
Applicant Holder Full Name: MICRO LABS LTD
Marketing Status: Prescription
Patent and Exclusivity Information