Composition
- Active ingredients
- FLUOXETINE HYDROCHLORIDE EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- FLUOXETINE HYDROCHLORIDE EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CapsuleNDA018936-008 · Discontinued
- FLUOXETINE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CapsuleNDA018936-007 · Discontinued
- FLUOXETINE HYDROCHLORIDE EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletThis page
- FLUOXETINE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA021860-001 · Discontinued
- FLUOXETINE HYDROCHLORIDE EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA021860-002 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA021860.
At a glance
- Brand name
- Sarafem
- Active substance
- fluoxetine hydrochloride
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Apil
- Status
- Discontinued
- FDA approval
- 19 May 2006
- Application
- NDA021860-003