Application Nr Approved Date Route Status External Links
ANDA204095 2015-06-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Desvenlafaxine Extended-Release Tablets, A Serotonin And Norepinephrine Reuptake Inhibitor (snri), Are Indicated For The Treatment Of Major Depressive Disorder (mdd) [see Clinical Studies (14) And Dosage And Administration (2.1)]. The Efficacy Of Desvenlafaxine Extended-Release Tablets Has Been Established In Four Short-Term (8-Week, Placebo-Controlled Studies) And Two Maintenance Studies In Adult Outpatients Who Met Dsm-Iv Criteria For Major Depressive Disorder. Desvenlafaxine Extended-Release Tablets Are A Serotonin And Norepinephrine Reuptake Inhibitor (snri) Indicated For The Treatment Of Major Depressive Disorder (mdd) (1).

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. 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.
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Ferric Oxide Red FERRIC OXIDE RED Molecular
7. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Desvenlafaxine Succinate DESVENLAFAXINE SUCCINATE ZINC2525885

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