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Generated: January 20, 2018

DrugPatentWatch Database Preview

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 three suppliers. Additional details are available on the SARAFEM profile page.

The generic ingredient in SARAFEM is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Seventy-four 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
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 021860
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 021860
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SARAFEM fluoxetine hydrochloride TABLET;ORAL 021860 NDA Allergan, Inc. 0430-0210 0430-0210-14 4 BLISTER PACK in 1 CARTON (0430-0210-14) > 7 TABLET in 1 BLISTER PACK
SARAFEM fluoxetine hydrochloride TABLET;ORAL 021860 NDA Allergan, Inc. 0430-0220 0430-0220-14 4 BLISTER PACK in 1 CARTON (0430-0220-14) > 7 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:May 19, 2006TE:AB1RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:May 19, 2006TE:AB1RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:May 19, 2006TE:AB1RLD:Yes

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