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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Fish and Richardson
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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065447

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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

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US Department of Justice
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