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Serving leading biopharmaceutical companies globally:

QuintilesIMS
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Federal Trade Commission
McKesson
Chubb
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AstraZeneca
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Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065389

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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
Tradename:DEMECLOCYCLINE HYDROCHLORIDE
Applicant:Akorn
Ingredient:demeclocycline hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065389
Ingredient-typeTetracyclines
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

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US Department of Justice
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Dow
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Novartis
Argus Health
Farmers Insurance

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