Application Nr Approved Date Route Status External Links
NDA022370 2011-08-01 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Conzip 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. Limitation 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/long-Acting Opioid Formulations [see Warnings And Precautions (5.1)], Reserve Conzip 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. Conzip Is Not Indicated As An As-Needed (prn) Analgesic. Conzip 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 Conzip 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) Conzip Is Not Indicated As An As-Needed (prn) Analgesic. (1)

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
2. Shellac SHELLAC Unresolved
3. D&c Yellow No. 10 D&C YELLOW NO. 10 Molecular DYE-Dye
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Povidone K30 POVIDONE K30 Unresolved
6. Starch, Corn STARCH, CORN Unresolved
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. Sucrose Stearate SUCROSE STEARATE Molecular
9. Hypromelloses HYPROMELLOSES Unresolved
10. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
11. 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.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE ZINC853

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