Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091001

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NISOLDIPINE (NISOLDIPINE)
8.5MG
Marketing Status: Prescription

Active Ingredient: NISOLDIPINE
Proprietary Name: NISOLDIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 8.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091001
Product Number: 001
Approval Date: Jan 26, 2011
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NISOLDIPINE (NISOLDIPINE)
17MG
Marketing Status: Prescription

Active Ingredient: NISOLDIPINE
Proprietary Name: NISOLDIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 17MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091001
Product Number: 002
Approval Date: Jan 26, 2011
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NISOLDIPINE (NISOLDIPINE)
25.5MG
Marketing Status: Prescription

Active Ingredient: NISOLDIPINE
Proprietary Name: NISOLDIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 25.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A091001
Product Number: 003
Approval Date: Jan 26, 2011
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NISOLDIPINE (NISOLDIPINE)
34MG
Marketing Status: Prescription

Active Ingredient: NISOLDIPINE
Proprietary Name: NISOLDIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 34MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091001
Product Number: 004
Approval Date: Jan 26, 2011
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information