Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Check market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

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

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065425

« Back to Dashboard
NDA 065425 describes DEMECLOCYCLINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharm, Epic Pharma Llc, Barr, Akorn, and Impax Labs, and is included in five NDAs. It is available from nine 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. Ten suppliers are listed for this compound. Additional details are available on the demeclocycline hydrochloride profile page.

Summary for NDA: 065425

Amneal Pharm
demeclocycline hydrochloride
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065425


Suppliers and Packaging for NDA: 065425

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
demeclocycline hydrochloride
TABLET;ORAL 065425 ANDA Major Pharmaceuticals 0904-6180 0904-6180-61 100 BLISTER PACK in 1 CARTON (0904-6180-61) > 1 TABLET in 1 BLISTER PACK
demeclocycline hydrochloride
TABLET;ORAL 065425 ANDA Major Pharmaceuticals 0904-6181 0904-6181-96 48 TABLET in 1 BOTTLE (0904-6181-96)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Feb 27, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Feb 27, 2008TE:ABRLD:Yes

Complete Access Available with Subscription
« Back to Dashboard

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

How are People Using DrugPatentWatch?

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.