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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200065

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NDA 200065 describes DOXYCYCLINE, which is a drug marketed by Alembic Pharms Ltd, G And W Labs Inc, Impax Labs Inc, Lupin Ltd, Mayne Pharma Inc, Mylan Pharms Inc, Par Pharm, Sandoz Inc, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms Usa Inc, Chartwell Life Sci, Mylan Labs Ltd, West-ward Pharms Int, Heritage Pharms Inc, Lannett Co Inc, Mylan, Sun Pharm Industries, Pliva, Medicis, Actavis Labs Fl Inc, Amneal Pharms, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Pvt Form, Ranbaxy, Superpharm, Warner Chilcott, Actavis Elizabeth, Prinston Inc, Amneal Pharms Co, Caribe Holdings, Epic Pharma Llc, Ivax Sub Teva Pharms, Larken Labs, Novel Labs Inc, and Vintage Pharms, and is included in seventy-eight NDAs. It is available from thirty-nine 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-eight suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 200065
Tradename:DOXYCYCLINE
Applicant:Impax Labs Inc
Ingredient:doxycycline
Patents:0
Therapeutic Class:Antibacterials
Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 200065
Ingredient-typeTetracyclines
Medical Subject Heading (MeSH) Categories for 200065
Suppliers and Packaging for NDA: 200065
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE doxycycline CAPSULE;ORAL 200065 ANDA Impax Generics 0115-1327 N 0115-1327-01
DOXYCYCLINE doxycycline CAPSULE;ORAL 200065 ANDA Impax Generics 0115-1327 N 0115-1327-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Feb 17, 2011TE:ABRLD:No

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