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Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021997

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NDA 021997 describes EDLUAR, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the EDLUAR profile page.

The generic ingredient in EDLUAR is zolpidem tartrate. There are thirty-two drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
Summary for 021997
Tradename:EDLUAR
Applicant:Mylan Speciality Lp
Ingredient:zolpidem tartrate
Patents:4
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
Pharmacology for NDA: 021997
Ingredient-typePyridines
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression
Suppliers and Packaging for NDA: 021997
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997 NDA Meda Pharmaceuticals 0037-6010 N 0037-6010-02
EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997 NDA Meda Pharmaceuticals 0037-6010 N 0037-6010-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength5MG
Approval Date:Mar 13, 2009TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Sep 24, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET
Patent:➤ Sign UpPatent Expiration:Sep 24, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET
Patent:➤ Sign UpPatent Expiration:Feb 25, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET

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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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