Product Details for ANDA 079051
NISOLDIPINE (NISOLDIPINE)
20MG
Marketing Status: Prescription
30MG
Marketing Status: Prescription
40MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
Active Ingredient: NISOLDIPINE
Proprietary Name: NISOLDIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code:
Application Number: A079051
Product Number: 001
Approval Date: Jul 25, 2008
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
NISOLDIPINE (NISOLDIPINE)
Proprietary Name: NISOLDIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code:
Application Number: A079051
Product Number: 001
Approval Date: Jul 25, 2008
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
30MG
Marketing Status: Prescription
Active Ingredient: NISOLDIPINE
Proprietary Name: NISOLDIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A079051
Product Number: 002
Approval Date: Jul 25, 2008
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
NISOLDIPINE (NISOLDIPINE)
Proprietary Name: NISOLDIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A079051
Product Number: 002
Approval Date: Jul 25, 2008
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
40MG
Marketing Status: Prescription
Active Ingredient: NISOLDIPINE
Proprietary Name: NISOLDIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code:
Application Number: A079051
Product Number: 003
Approval Date: Jul 25, 2008
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: NISOLDIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code:
Application Number: A079051
Product Number: 003
Approval Date: Jul 25, 2008
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information