Details for New Drug Application (NDA): 021860
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NDA 021860 describes SARAFEM, which is a drug marketed by Eli Lilly And Co and Apil and is included in two NDAs. It is available from one supplier. Additional details are available on the SARAFEM profile page.
The generic ingredient in SARAFEM is fluoxetine hydrochloride. There is one drug master file entry for this compound. Sixty suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
The generic ingredient in SARAFEM is fluoxetine hydrochloride. There is one drug master file entry for this compound. Sixty suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 021860
| Tradename: | SARAFEM |
| Applicant: | Apil |
| Ingredient: | fluoxetine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 021860
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | May 19, 2006 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | May 19, 2006 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | May 19, 2006 | TE: | RLD: | Yes | |||||
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