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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Chubb
Covington
Citi
Cantor Fitzgerald
Merck
Johnson and Johnson
Mallinckrodt
Baxter
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Generated: August 19, 2017

DrugPatentWatch Database Preview

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 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-one suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.

Summary for NDA: 018936

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antidepressants
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Dec 29, 1987TE:AB1RLD:Yes
Regulatory Exclusivity Expiration:Jul 26, 2016
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:► SubscribePatent Expiration:Nov 1, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:PROZAC AND OLANZAPINE IN COMBINATION FOR THE ACUTE TREATMENT OF TREATMENT RESISTANT DEPRESSION IN ADULTS

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 40MG BASE
Approval Date:Jun 15, 1999TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jul 26, 2016
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired Orange Book Patents for NDA: 018936

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eli Lilly And Co
PROZAC
fluoxetine hydrochloride
CAPSULE;ORAL018936-003Jun 15, 1999► Subscribe► Subscribe
Eli Lilly And Co
PROZAC
fluoxetine hydrochloride
CAPSULE;ORAL018936-001Dec 29, 1987► Subscribe► Subscribe
Eli Lilly And Co
PROZAC
fluoxetine hydrochloride
CAPSULE;ORAL018936-001Dec 29, 1987► Subscribe► Subscribe
Eli Lilly And Co
PROZAC
fluoxetine hydrochloride
CAPSULE;ORAL018936-006Dec 23, 1992► Subscribe► Subscribe
Eli Lilly And Co
PROZAC
fluoxetine hydrochloride
CAPSULE;ORAL018936-001Dec 29, 1987► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Federal Trade Commission
McKinsey
Daiichi Sankyo
US Army
McKesson
Healthtrust
US Department of Justice
Cantor Fitzgerald
Citi

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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