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Details for New Drug Application (NDA): 022196

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NDA 022196 describes ZOLPIMIST, which is a drug marketed by Amherst Pharms Llc and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the ZOLPIMIST profile page.

The generic ingredient in ZOLPIMIST 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: 022196

Tradename:
ZOLPIMIST
Applicant:
Amherst Pharms Llc
Ingredient:
zolpidem tartrate
Patents:2
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 022196

Ingredient-typePyridines
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression

Suppliers and Packaging for NDA: 022196

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLPIMIST
zolpidem tartrate
SPRAY, METERED;ORAL 022196 NDA ECR Pharmaceuticals 0095-0950 0095-0950-05 1 CONTAINER in 1 CARTON (0095-0950-05) > 60 SPRAY, METERED in 1 CONTAINER
ZOLPIMIST
zolpidem tartrate
SPRAY, METERED;ORAL 022196 NDA ECR Pharmaceuticals 0095-0950 0095-0950-09 1 CONTAINER in 1 CARTON (0095-0950-09) > 8 SPRAY, METERED in 1 CONTAINER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;ORALStrength5MG/SPRAY
Approval Date:Dec 19, 2008TE:RLD:Yes
Patent:7,632,517Patent Expiration:Oct 1, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF TRANSIENT INSOMNIA
Patent:8,236,285Patent Expiration:Aug 7, 2032Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF TRANSIENT INSOMNIA


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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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