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McKesson
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US Department of Justice
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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065103

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NDA 065103 describes DOXYCYCLINE HYCLATE, which is a drug marketed by Pliva, Medicis, Actavis Labs Fl Inc, Amneal Pharms, Chartwell Life Sci, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Mylan, Par Pharm, Pvt Form, Ranbaxy, Sun Pharm Industries, Superpharm, Warner Chilcott, Watson Labs, West-ward Pharms Int, Actavis Elizabeth, Heritage Pharms Inc, Impax Labs Inc, Mylan Pharms Inc, Prinston Inc, Amneal Pharms Co, Caribe Holdings, Epic Pharma Llc, Ivax Sub Teva Pharms, Lannett, Larken Labs, Lupin Ltd, Mayne Pharma Inc, Novel Labs Inc, Vintage Pharms, and Zydus Pharms Usa Inc, and is included in fifty-two NDAs. It is available from eighty-five suppliers. Additional details are available on the DOXYCYCLINE HYCLATE profile page.

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

Summary for 065103

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

Suppliers and Packaging for NDA: 065103

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 065103 ANDA C.O. Truxton, Inc. 0463-2013 0463-2013-05 50 CAPSULE in 1 BOTTLE (0463-2013-05)
DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 065103 ANDA C.O. Truxton, Inc. 0463-2013 0463-2013-50 500 CAPSULE in 1 BOTTLE (0463-2013-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:May 13, 2005TE:RLD:No


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Serving leading biopharmaceutical companies globally:

McKinsey
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Covington
Fish and Richardson
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