Details for New Drug Application (NDA): 209777
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The generic ingredient in ROXYBOND is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Forty-five 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 AUTHORIZED GENERIC | Galephar Pharmaceutical Research Inc. | 66277-345 | 66277-345-10 | 100 TABLET, COATED in 1 BOTTLE (66277-345-10) |
ROXYBOND | oxycodone hydrochloride | TABLET;ORAL | 209777 | NDA AUTHORIZED GENERIC | Galephar Pharmaceutical Research Inc. | 66277-346 | 66277-346-10 | 100 TABLET, COATED in 1 BOTTLE (66277-346-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Apr 20, 2017 | TE: | RLD: | No | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 12, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | 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: | ⤷ Sign Up | Patent Expiration: | Aug 12, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? |
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