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Details for New Drug Application (NDA): 209777
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NDA 209777 describes ROXYBOND, which is a drug marketed by Inspirion Delivery and is included in one NDA. There are two patents protecting this drug. Additional details are available on the ROXYBOND profile page.
The generic ingredient in ROXYBOND is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Additional details are available on the oxycodone hydrochloride profile page.
The generic ingredient in ROXYBOND is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Additional details are available on the oxycodone hydrochloride profile page.
Summary for 209777
| Tradename: | ROXYBOND |
| Applicant: | Inspirion Delivery |
| Ingredient: | oxycodone hydrochloride |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Apr 20, 2017 | TE: | RLD: | No | |||||
| Regulatory Exclusivity Expiration: | Apr 20, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | Start Trial | Patent Expiration: | Aug 12, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Aug 12, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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