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Serving leading biopharmaceutical companies globally:

Citi
UBS
Fish and Richardson
Julphar
Express Scripts
Teva
Cipla
Harvard Business School
Healthtrust
Accenture

Generated: October 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065454

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NDA 065454 describes DOXYCYCLINE, which is a drug marketed by Heritage Pharms Inc, Mylan Labs Ltd, Zydus Pharms Usa Inc, Mylan, Sandoz Inc, Lupin Ltd, Watson Labs, G And W Labs Inc, West-ward Pharms Int, Sun Pharm Inds Ltd, Chartwell Life Sci, Par Pharm, Alembic Pharms Ltd, Impax Labs Inc, Sun Pharm Inds, Mylan Pharms Inc, Lannett, Mayne Pharma Inc, Hikma Intl Pharms, Mutual Pharm, Halsey, Actavis Labs Fl Inc, Pvt Form, Actavis Elizabeth, Vintage Pharms, Novel Labs Inc, Heather, Interpharm, Ivax Sub Teva Pharms, Superpharm, Caribe Holdings, Amneal Pharms Co, Ranbaxy, Medicis, Epic Pharma Llc, Pliva, Larken Labs, Amneal Pharms, Warner Chilcott, and Prinston Inc, and is included in seventy-seven NDAs. It is available from thirty-six suppliers. Additional details are available on the DOXYCYCLINE profile page.

The generic ingredient in DOXYCYCLINE is doxycycline hyclate. There are twenty-seven drug master file entries for this compound. Ninety-three suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

Summary for NDA: 065454

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Dermatological Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 065454

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE
doxycycline
FOR SUSPENSION;ORAL 065454 ANDA Harris Pharmaceutical, Inc 67405-475 67405-475-62 60 mL in 1 BOTTLE, GLASS (67405-475-62)
DOXYCYCLINE
doxycycline
FOR SUSPENSION;ORAL 065454 ANDA CHARTWELL GOVERNMENTAL & SPECIALTY RX LLC 68999-417 68999-417-01 60 mL in 1 BOTTLE, GLASS (68999-417-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 25MG BASE/5ML
Approval Date:Jul 16, 2008TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

US Department of Justice
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Julphar
Novartis
McKinsey
QuintilesIMS
Queensland Health
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Farmers Insurance
US Army

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