Application Nr Approved Date Route Status External Links
ANDA040419 2001-05-31 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Acetaminophen And Codeine Phosphate Tablets Are Indicated For The Relief Of Mild To Moderately Severe Pain.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. 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.
2. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
3. Povidones POVIDONES Unresolved
4. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 2 Total)

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