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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Medtronic
Farmers Insurance
McKesson
Fish and Richardson
Queensland Health
Cantor Fitzgerald
US Department of Justice
McKinsey
Deloitte
Novartis

Generated: November 19, 2017

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

Summary for 021860

Tradename:
1
Applicant:
1
Ingredient:
1
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

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving leading biopharmaceutical companies globally:

Harvard Business School
Federal Trade Commission
Colorcon
Medtronic
Dow
Mallinckrodt
Express Scripts
McKesson
Moodys
Farmers Insurance

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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