General MedicationsORALGeneric
SELFEMRA
FLUOXETINE HYDROCHLORIDE
Standard Dose
EQ 15MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary
Approval overview SELFEMRA is listed in Drugs@FDA under application 200151 (ANDA).
Review priority: STANDARD Marketing status: Discontinued Active ingredient FLUOXETINE HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 15MG BASE Sponsor TEVA PHARMS USA Submission history Latest submission status date: 2023-08-18 00:00:00.
Structured Monograph
Clinical summary
Approval overview SELFEMRA is listed in Drugs@FDA under application 200151 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient FLUOXETINE HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 15MG BASE Sponsor TEVA PHARMS USA Submission history Latest submission status date: 2023-08-18 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Discontinued
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.