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Serving leading biopharmaceutical companies globally:

Moodys
Merck
Deloitte
Julphar
Queensland Health
McKesson
Fuji
Novartis
Johnson and Johnson
Colorcon

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200856

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NDA 200856 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 200856
Tradename:DOXYCYCLINE HYCLATE
Applicant:Heritage Pharms Inc
Ingredient:doxycycline hyclate
Patents:0
Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 200856
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE HYCLATE doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 200856 ANDA Heritage Pharmaceuticals Inc. 23155-141 N 23155-141-05
DOXYCYCLINE HYCLATE doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 200856 ANDA Heritage Pharmaceuticals Inc. 23155-141 N 23155-141-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 75MG BASE
Approval Date:Apr 30, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 100MG BASE
Approval Date:Apr 30, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 150MG BASE
Approval Date:Apr 30, 2013TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
US Army
Argus Health
Fish and Richardson
Covington
Colorcon
Teva
Merck
Johnson and Johnson

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