Application Nr Approved Date Route Status External Links
NDA206544 2015-10-02 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Morphabond Er Is Indicated For The Management Of Pain Severe Enough To Require Daily, Around-The-Clock, Long-Term Opioid Treatment And For Which Alternative Treatment Options Are Inadequate. Limitations Of Use Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses, And Because Of The Greater Risks Of Overdose And Death With Extended-Release Opioid Formulations [see Warnings And Precautions (5.1)], Reserve Morphabond Er For Use In Patients For Whom Alternative Treatment Options (e.g., Non-Opioid Analgesics Or Immediate-Release Opioids) Are Ineffective, Not Tolerated, Or Would Be Otherwise Inadequate To Provide Sufficient Management Of Pain. Morphabond Er Is Not Indicated As An As-Needed (prn) Analgesic. Morphabond Er Is An Opioid Agonist Indicated For The Management Of Pain Severe Enough To Require Daily, Around-The-Clock, Long-Term Opioid Treatment And For Which Alternative Treatment Options Are Inadequate. (1) Limitations Of Use Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses, And Because Of The Greater Risks Of Overdose And Death With Extended-Release Opioid Formulations, Reserve Morphabond Er For Use In Patients For Whom Alternative Treatment Options (e.g., Non-Opioid Analgesics Or Immediate-Release Opioids) Are Ineffective, Not Tolerated, Or Would Be Otherwise Inadequate To Provide Sufficient Management Of Pain. (1) Morphabond Er Is Not Indicated As An As-Needed (prn) Analgesic. (1)

All Formulated Excipients (15 Total)

Name Structure Kind Function Status
1. Xanthan Gum XANTHAN GUM Unresolved EMUL-Emulsifier FS-Substances permitted as optional ingredient in a standardized food.
2. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
3. Sodium Alginate SODIUM ALGINATE Unresolved BC-Boiler compound , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.
4. Alginic Acid ALGINIC ACID Unresolved GRAS-Generally recognized as safe.
5. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
6. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
7. 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.
8. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
9. 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.
10. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
11. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
12. Isopropyl Alcohol ISOPROPYL ALCOHOL Molecular
13. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
14. Butyl Alcohol BUTYL ALCOHOL Molecular MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
15. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Morphine Sulfate MORPHINE SULFATE ZINC3812983

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