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-six suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
The generic ingredient in ZOLPIMIST is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-six 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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SPRAY, METERED;ORAL | Strength | 5MG/SPRAY | ||||
| Approval Date: | Dec 19, 2008 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 7, 2032 | Product Flag? | Y | Substance Flag? | Y | Delist 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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