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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022196


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NDA 022196 describes ZOLPIMIST, which is a drug marketed by Aytu and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ZOLPIMIST profile page.

The generic ingredient in ZOLPIMIST is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
Summary for 022196
Tradename:ZOLPIMIST
Applicant:Aytu
Ingredient:zolpidem tartrate
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 022196
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 Aytu BioScience, Inc. 69654-510 69654-510-30 1 BOTTLE, SPRAY in 1 CARTON (69654-510-30) > 30 SPRAY, METERED in 1 BOTTLE, SPRAY
ZOLPIMIST zolpidem tartrate SPRAY, METERED;ORAL 022196 NDA Aytu BioScience, Inc. 69654-510 69654-510-60 1 BOTTLE, SPRAY in 1 CARTON (69654-510-60) > 60 SPRAY, METERED in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;ORALStrength5MG/SPRAY
Approval Date:Dec 19, 2008TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Aug 7, 2032Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF TRANSIENT INSOMNIA

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Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
McKesson
Johnson and Johnson
McKinsey
Moodys

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