Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
Johnson and Johnson
UBS
AstraZeneca
Novartis
Deloitte
US Army
Chubb
Baxter

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018936

« Back to Dashboard

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

Summary for 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 CoPROZACfluoxetine hydrochlorideCAPSULE;ORAL018936-001Dec 29, 1987► Subscribe► Subscribe
Eli Lilly And CoPROZACfluoxetine hydrochlorideCAPSULE;ORAL018936-001Dec 29, 1987► Subscribe► Subscribe
Eli Lilly And CoPROZACfluoxetine hydrochlorideCAPSULE;ORAL018936-001Dec 29, 1987► Subscribe► Subscribe
Eli Lilly And CoSARAFEMfluoxetine hydrochlorideCAPSULE;ORAL018936-008Jul 6, 2000► Subscribe► Subscribe
Eli Lilly And CoPROZACfluoxetine hydrochlorideCAPSULE;ORAL018936-003Jun 15, 1999► Subscribe► Subscribe
Eli Lilly And CoPROZACfluoxetine hydrochlorideCAPSULE;ORAL018936-003Jun 15, 1999► Subscribe► Subscribe
Eli Lilly And CoPROZACfluoxetine hydrochlorideCAPSULE;ORAL018936-001Dec 29, 1987► Subscribe► Subscribe
Eli Lilly And CoPROZACfluoxetine hydrochlorideCAPSULE;ORAL018936-004Jun 15, 1999► Subscribe► Subscribe
Eli Lilly And CoPROZACfluoxetine hydrochlorideCAPSULE;ORAL018936-001Dec 29, 1987► Subscribe► Subscribe
Eli Lilly And CoPROZACfluoxetine hydrochlorideCAPSULE;ORAL018936-006Dec 23, 1992► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Healthtrust
Merck
QuintilesIMS
Chubb
Julphar
Dow
Fish and Richardson
Boehringer Ingelheim
Federal Trade Commission
Cipla

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot