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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 ten suppliers. There is one patent protecting this drug. Additional details are available on the NIASPAN TITRATION STARTER PACK profile page.

The generic ingredient in NIASPAN TITRATION STARTER PACK is niacin. There are thirteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the niacin profile page.

Summary for NDA: 020381

Tradename:
NIASPAN
Applicant:
Abbvie
Ingredient:
niacin
Patents:2
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020381

Ingredient-typeNicotinic Acids

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. 0074-3074 0074-3074-07 1 BLISTER PACK in 1 CARTON (0074-3074-07) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL 020381 NDA AbbVie Inc. 0074-3074 0074-3074-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0074-3074-30)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength375MG
Approval Date:Jul 28, 1997TE:RLD:No
Patent:6,080,428Patent Expiration:May 27, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jul 28, 1997TE:ABRLD:No
Patent:6,469,035Patent 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:6,080,428Patent Expiration:May 27, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT

Expired Orange Book Patents for NDA: 020381

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-001Jul 28, 19976,129,930► subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-002Jul 28, 19976,746,691► subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-003Jul 28, 19977,998,506► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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