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Last Updated: November 21, 2019

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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-three drug master file entries for this compound. Fifty-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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021997
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 0037-6010-02 20 BLISTER PACK in 1 BOX, UNIT-DOSE (0037-6010-02) > 2 TABLET in 1 BLISTER PACK
EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997 NDA Meda Pharmaceuticals 0037-6010 0037-6010-30 3 BLISTER PACK in 1 CARTON (0037-6010-30) > 10 TABLET in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 021997
Tradename Dosage Ingredient NDA Submissiondate
EDLUAR TABLET;SUBLINGUAL zolpidem tartrate 021997 2010-04-29

Profile for product number 001

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

Expired US Patents for NDA 021997

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-001 Mar 13, 2009   Start Trial   Start Trial
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-002 Mar 13, 2009   Start Trial   Start Trial
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-002 Mar 13, 2009   Start Trial   Start Trial
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-001 Mar 13, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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