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Generated: March 20, 2019

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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 six 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. Twenty-one 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:1
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)

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
Patent:➤ Try a Free TrialPatent Expiration:Mar 15, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF REDUCING THE CAPACITY OF EXTENDED RELEASE NICOTINIC ACID TO PROVOKE A FLUSHING REACTION BY PRETREATING AN INDIVIDUAL WITH A FLUSH INHIBITING AGENT PRIOR TO THE ADMINISTRATION OF THE EXTENDED RELEASE NICOTINIC ACID
Patent:➤ Try a Free TrialPatent Expiration:Mar 15, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION IN ELEVATED TC AND LDL-C BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN

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 020381-004 Jul 28, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-002 Jul 28, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-003 Jul 28, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-003 Jul 28, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-003 Jul 28, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-004 Jul 28, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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