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

Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Covington
US Department of Justice
Baxter
Federal Trade Commission
Cipla
Cerilliant
Merck
Deloitte

Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065134

« Back to Dashboard

NDA 065134 describes DOXYCYCLINE HYCLATE, which is a drug marketed by Pliva, Medicis, Actavis Labs Fl Inc, Alembic Pharms Ltd, Amneal Pharms, Chartwell Life Sci, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Mylan, Par Pharm, Pvt Form, Ranbaxy, Sun Pharm Industries, Superpharm, Warner Chilcott, Watson Labs, Zydus Pharms Usa Inc, West-ward Pharms Int, Actavis Elizabeth, Heritage Pharms Inc, Impax Labs Inc, Mylan Pharms Inc, Prinston Inc, Amneal Pharms Co, Caribe Holdings, Epic Pharma Llc, Ivax Sub Teva Pharms, Lannett Co Inc, Larken Labs, Lupin Ltd, Mayne Pharma Inc, Novel Labs Inc, and Vintage Pharms, and is included in fifty-four NDAs. It is available from ninety-one suppliers. Additional details are available on the DOXYCYCLINE HYCLATE profile page.

The generic ingredient in DOXYCYCLINE HYCLATE is doxycycline hyclate. There are twenty-seven drug master file entries for this compound. Ninety-nine suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 065134
Tradename:DOXYCYCLINE HYCLATE
Applicant:Sun Pharm Industries
Ingredient:doxycycline hyclate
Patents:0
Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 065134
Ingredient-typeTetracyclines
Suppliers and Packaging for NDA: 065134
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 065134 ANDA Sun Pharmaceutical Industries, Inc. 53489-647 N 53489-647-01
DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 065134 ANDA Sun Pharmaceutical Industries, Inc. 53489-647 N 53489-647-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:May 13, 2005TE:ABRLD:No

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Merck
Julphar
Queensland Health
US Army
Deloitte
AstraZeneca
Cantor Fitzgerald
Daiichi Sankyo
Fuji

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.