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Details for New Drug Application (NDA): 209777
NDA 209777 describes ROXYBOND, which is a drug marketed by Daiichi Sankyo Inc 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 ROXYBOND profile page.
The generic ingredient in ROXYBOND is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Fifty-four suppliers are listed 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. Fifty-four suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.
Summary for 209777
| Tradename: | ROXYBOND |
| Applicant: | Daiichi Sankyo Inc |
| Ingredient: | oxycodone hydrochloride |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209777
| Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 209777
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROXYBOND | oxycodone hydrochloride | TABLET;ORAL | 209777 | NDA | Daiichi Sankyo Inc. | 65597-501 | 65597-501-10 | 100 TABLET, COATED in 1 BOTTLE, PLASTIC (65597-501-10) |
| ROXYBOND | oxycodone hydrochloride | TABLET;ORAL | 209777 | NDA | Daiichi Sankyo Inc. | 65597-502 | 65597-502-10 | 100 TABLET, COATED in 1 BOTTLE, PLASTIC (65597-502-10) |
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: | ➤ Try a Free Trial | Patent Expiration: | Aug 12, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
| Approval Date: | Apr 20, 2017 | TE: | RLD: | No | |||||
| Regulatory Exclusivity Expiration: | Apr 20, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
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