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Last Updated: July 10, 2020

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Details for New Drug Application (NDA): 018936


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NDA 018936 describes SARAFEM, which is a drug marketed by Eli Lilly And Co and Apil and is included in two NDAs. It is available from two 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. Sixty suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 018936
Tradename:SARAFEM
Applicant:Eli Lilly And Co
Ingredient:fluoxetine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018936
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 018936
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936 NDA Dista Products Company 0777-3104 0777-3104-02 100 CAPSULE in 1 BOTTLE (0777-3104-02)
SARAFEM fluoxetine hydrochloride CAPSULE;ORAL 018936 NDA Dista Products Company 0777-3104 0777-3104-02 100 CAPSULE in 1 BOTTLE (0777-3104-02)
Paragraph IV (Patent) Challenges for 018936
Tradename Dosage Ingredient NDA Submissiondate
PROZAC CAPSULE;ORAL fluoxetine hydrochloride 018936
SARAFEM CAPSULE;ORAL fluoxetine hydrochloride 018936

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Dec 29, 1987TE:AB1RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 40MG BASE
Approval Date:Jun 15, 1999TE:ABRLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 60MG BASE
Approval Date:Jun 15, 1999TE:RLD:No

Expired US Patents for NDA 018936

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-004 Jun 15, 1999   Start Trial   Start Trial
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-001 Dec 29, 1987   Start Trial   Start Trial
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-001 Dec 29, 1987   Start Trial   Start Trial
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-006 Dec 23, 1992   Start Trial   Start Trial
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-001 Dec 29, 1987   Start Trial   Start Trial
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-001 Dec 29, 1987   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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