Make Better Decisions

  • Identify first generic entrants
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

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

Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Federal Trade Commission
Cantor Fitzgerald

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065389

« Back to Dashboard

NDA 065389 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 065389
Ingredient:demeclocycline hydrochloride
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065389
Medical Subject Heading (MeSH) Categories for 065389
Suppliers and Packaging for NDA: 065389
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEMECLOCYCLINE HYDROCHLORIDE demeclocycline hydrochloride TABLET;ORAL 065389 ANDA VersaPharm Incorporated 61748-113 61748-113-48 48 TABLET, FILM COATED in 1 BOTTLE (61748-113-48)
DEMECLOCYCLINE HYDROCHLORIDE demeclocycline hydrochloride TABLET;ORAL 065389 ANDA VersaPharm Incorporated 61748-115 61748-115-01 100 TABLET, FILM COATED in 1 BOTTLE (61748-115-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Dec 1, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Dec 1, 2008TE:ABRLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

US Department of Justice
Chinese Patent Office
Argus Health
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.