Details for New Drug Application (NDA): 209777
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NDA 209777 describes ROXYBOND, which is a drug marketed by Protega Pharms and is included in one NDA. It is available from one supplier. 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. Thirty-seven 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.
Summary for 209777
| Tradename: | ROXYBOND |
| Applicant: | Protega Pharms |
| Ingredient: | oxycodone hydrochloride |
| Patents: | 2 |
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 | Protega Pharmaceuticals Inc | 81140-101 | 81140-101-10 | 100 TABLET, COATED in 1 BOTTLE (81140-101-10) |
| ROXYBOND | oxycodone hydrochloride | TABLET;ORAL | 209777 | NDA | Protega Pharmaceuticals Inc | 81140-102 | 81140-102-10 | 100 TABLET, COATED in 1 BOTTLE (81140-102-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Apr 20, 2017 | TE: | RLD: | No | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Aug 12, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Aug 12, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
| Approval Date: | Apr 20, 2017 | TE: | RLD: | No | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Aug 12, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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