Details for New Drug Application (NDA): 022328
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NDA 022328 describes INTERMEZZO, which is a drug marketed by Purdue Pharma and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the INTERMEZZO profile page.
The generic ingredient in INTERMEZZO 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.
The generic ingredient in INTERMEZZO 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 022328
| Tradename: | INTERMEZZO |
| Applicant: | Purdue Pharma |
| Ingredient: | zolpidem tartrate |
| Patents: | 4 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;SUBLINGUAL | Strength | 1.75MG | ||||
| Approval Date: | Nov 23, 2011 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Apr 15, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD FOR TREATING INSOMNIA | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Feb 16, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR TREATING INSOMNIA | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Aug 20, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING MIDDLE-OF-THE-NIGHT INSOMNIA | ||||||||
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