Make Better Decisions

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information
➤ Start Trial

or, See Plans & Pricing

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

Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Boehringer Ingelheim
Cantor Fitzgerald

Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065447

« Back to Dashboard

NDA 065447 describes DEMECLOCYCLINE HYDROCHLORIDE, which is a drug marketed by Akorn, Amneal Pharm, Barr, Epic Pharma Llc, and Impax Labs, and is included in five NDAs. It is available from eleven suppliers. Additional details are available on the DEMECLOCYCLINE HYDROCHLORIDE profile page.

The generic ingredient in DEMECLOCYCLINE HYDROCHLORIDE is demeclocycline hydrochloride. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the demeclocycline hydrochloride profile page.
Summary for 065447
Applicant:Epic Pharma Llc
Ingredient:demeclocycline hydrochloride
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065447
Medical Subject Heading (MeSH) Categories for 065447
Suppliers and Packaging for NDA: 065447
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEMECLOCYCLINE HYDROCHLORIDE demeclocycline hydrochloride TABLET;ORAL 065447 ANDA Marlex Pharmaceuticals Inc 10135-625 E 10135-625-01
DEMECLOCYCLINE HYDROCHLORIDE demeclocycline hydrochloride TABLET;ORAL 065447 ANDA Marlex Pharmaceuticals Inc 10135-626 E 10135-626-48

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Aug 18, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Aug 18, 2015TE: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:

Fish and Richardson
Harvard Business School
US Army
Argus Health

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.