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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 Meda Pharms and is included in one NDA. It is available from one supplier. There are three 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-one drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

Summary for NDA: 021997

Tradename:
EDLUAR
Applicant:
Meda Pharms
Ingredient:
zolpidem tartrate
Patents:3
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 Inc. 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 Inc. 0037-6010 0037-6010-30 3 BLISTER PACK in 1 CARTON (0037-6010-30) > 10 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength5MG
Approval Date:Mar 13, 2009TE:ABRLD:No
Patent:6,761,910Patent Expiration:Sep 24, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET
Patent:8,512,747Patent Expiration:Sep 24, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET
Patent:9,265,720Patent Expiration:May 13, 2030Product 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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