Application Nr Approved Date Route Status External Links
ANDA078783 2011-09-20 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Tramadol Hydrochloride Er Tablets Are Indicated For The Management Of Moderate To Moderately Severe Chronic Pain In Adults Who Require Around-The-Clock Treatment Of Their Pain For An Extended Period Of Time.

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Dibutyl Sebacate DIBUTYL SEBACATE Molecular
2. Ethylcelluloses ETHYLCELLULOSES Unresolved
3. 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.
4. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
5. Povidone K90 POVIDONE K90 Unresolved
6. Opacode S-1-17823 Black OPACODE S-1-17823 BLACK Unresolved
7. Ferrosoferric Oxide FERROSOFERRIC OXIDE Unresolved
8. Isopropyl Alcohol ISOPROPYL ALCOHOL Molecular
9. Butyl Alcohol BUTYL ALCOHOL Molecular MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
10. 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. Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE ZINC853

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