Application Nr Approved Date Route Status External Links
NDA209777 2017-04-20 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Roxybond Is Indicated For The Management Of Pain Severe Enough To Require An Opioid Analgesic And For Which Alternative Treatments Are Inadequate. Limitations Of Use Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses [see Warnings And Precautions (5.1)], Reserve Roxybond For Use In Patients For Whom Alternative Treatment Options (e.g., Non-Opioid Analgesics Or Opioid Combination Products): •have Not Been Tolerated Or Are Not Expected To Be Tolerated, •have Not Provided Adequate Analgesia Or Are Not Expected To Provide Adequate Analgesia. Roxybond Is An Opioid Agonist Indicated For The Management Of Pain Severe Enough To Require An Opioid Analgesic And For Which Alternative Treatments Are Inadequate. (1) Limitations Of Use (1) Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses, Reserve Roxybond For Use In Patients For Whom Alternative Treatment Options (e.g., Non-Opioid Analgesics Or Opioid Combination Products): •have Not Been Tolerated, Or Are Not Expected To Be Tolerated, •have Not Provided Adequate Analgesia Or Are Not Expected To Provide Adequate Analgesia.

All Formulated Excipients (19 Total)

Name Structure Kind Function Status
1. Ammonia AMMONIA Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Dibutyl Sebacate DIBUTYL SEBACATE Molecular
4. Ethylcelluloses ETHYLCELLULOSES Unresolved
5. Hypromelloses HYPROMELLOSES Unresolved
6. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
7. Isopropyl Alcohol ISOPROPYL ALCOHOL Molecular
8. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
9. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
10. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
11. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
12. Butyl Alcohol BUTYL ALCOHOL Molecular MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
13. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
14. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
15. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
16. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
17. Sodium Alginate SODIUM ALGINATE Unresolved BC-Boiler compound , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.
18. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
19. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE ZINC403533

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