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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020381

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NDA 020381 describes NIASPAN TITRATION STARTER PACK, which is a drug marketed by Abbvie and is included in one NDA. It is available from two suppliers. Additional details are available on the NIASPAN TITRATION STARTER PACK profile page.

The generic ingredient in NIASPAN TITRATION STARTER PACK is niacin. There are fourteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the niacin profile page.
Summary for 020381
Tradename:NIASPAN TITRATION STARTER PACK
Applicant:Abbvie
Ingredient:niacin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020381
Medical Subject Heading (MeSH) Categories for 020381
Suppliers and Packaging for NDA: 020381
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381 NDA AbbVie Inc. 0074-3265 0074-3265-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0074-3265-90)
NIASPAN TITRATION STARTER PACK niacin TABLET, EXTENDED RELEASE;ORAL 020381 NDA AbbVie Inc. 0074-3265 0074-3265-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0074-3265-90)
Paragraph IV (Patent) Challenges for 020381
Tradename Dosage Ingredient NDA Submissiondate
NIASPAN TABLET, EXTENDED RELEASE;ORAL niacin 020381
NIASPAN TITRATION STARTER PACK TABLET, EXTENDED RELEASE;ORAL niacin 020381

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength375MG
Approval Date:Jul 28, 1997TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jul 28, 1997TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:Jul 28, 1997TE:ABRLD:Yes

Expired US Patents for NDA 020381

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-002 Jul 28, 1997   Start Trial   Start Trial
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-001 Jul 28, 1997   Start Trial   Start Trial
Abbvie NIASPAN TITRATION STARTER PACK niacin TABLET, EXTENDED RELEASE;ORAL 020381-005 Jul 28, 1997   Start Trial   Start Trial
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-001 Jul 28, 1997   Start Trial   Start Trial
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-004 Jul 28, 1997   Start Trial   Start Trial
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-003 Jul 28, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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