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Last Updated: July 23, 2024

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. 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-seven 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

Profile for product number 001

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

Expired US Patents for NDA 022196

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Aytu ZOLPIMIST zolpidem tartrate SPRAY, METERED;ORAL 022196-001 Dec 19, 2008 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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