Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 079051

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NISOLDIPINE (NISOLDIPINE)
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)
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)
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