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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020381

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NIASPAN (NIACIN)
375MG
Marketing Status: Discontinued
Active Ingredient: NIACIN
Proprietary Name: NIASPAN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 375MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020381
Product Number: 001
Approval Date: Jul 28, 1997
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
NIASPAN (NIACIN)
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NIACIN
Proprietary Name: NIASPAN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020381
Product Number: 002
Approval Date: Jul 28, 1997
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
NIASPAN (NIACIN)
750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NIACIN
Proprietary Name: NIASPAN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020381
Product Number: 003
Approval Date: Jul 28, 1997
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
NIASPAN (NIACIN)
1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NIACIN
Proprietary Name: NIASPAN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020381
Product Number: 004
Approval Date: Jul 28, 1997
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
NIASPAN TITRATION STARTER PACK (NIACIN)
375MG;500MG;750MG
Marketing Status: Discontinued
Active Ingredient: NIACIN
Proprietary Name: NIASPAN TITRATION STARTER PACK
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 375MG;500MG;750MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020381
Product Number: 005
Approval Date: Jul 28, 1997
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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