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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Colorcon
Merck
Harvard Business School
Teva
Dow
Fuji
Express Scripts
Chubb

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062269

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NDA 062269 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-seven 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 062269
Tradename:DOXYCYCLINE HYCLATE
Applicant:Caribe Holdings
Ingredient:doxycycline hyclate
Patents:0
Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 062269
Ingredient-typeTetracyclines
Suppliers and Packaging for NDA: 062269
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 062269 ANDA C.O. Truxton, Inc. 0463-6000 N 0463-6000-50
DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 062269 ANDA PuraCap Laboratories LLC dba Blu Pharmaceuticals 24658-312 N 24658-312-10

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Nov 8, 1982TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Fuji
Express Scripts
Healthtrust
Covington
Federal Trade Commission
Teva
Fish and Richardson
Mallinckrodt

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