BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Deloitte
QuintilesIMS
Chubb
Cipla
Accenture
Mallinckrodt
Fish and Richardson
McKesson
Citi
Federal Trade Commission

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050641

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NDA 050641 describes MONODOX, which is a drug marketed by Aqua Pharms and is included in one NDA. It is available from five suppliers. Additional details are available on the MONODOX profile page.

The generic ingredient in MONODOX is doxycycline. There are twenty-seven drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the doxycycline profile page.
Summary for 050641
Tradename:MONODOX
Applicant:Aqua Pharms
Ingredient:doxycycline
Patents:0
Therapeutic Class:Antibacterials
Dermatological Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 050641
Suppliers and Packaging for NDA: 050641
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONODOX doxycycline CAPSULE;ORAL 050641 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-0410 0591-0410-01 100 CAPSULE in 1 BOTTLE (0591-0410-01)
MONODOX doxycycline CAPSULE;ORAL 050641 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-0411 0591-0411-50 50 CAPSULE in 1 BOTTLE (0591-0411-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Dec 29, 1989TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Feb 10, 1992TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Oct 18, 2006TE:ABRLD:Yes

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Serving leading biopharmaceutical companies globally:

Covington
Fish and Richardson
US Army
QuintilesIMS
Healthtrust
Farmers Insurance
Queensland Health
Chubb
Moodys

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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