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Generated: April 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205115

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NDA 205115 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, 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-seven suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 205115
Tradename:DOXYCYCLINE
Applicant:Zydus Pharms Usa Inc
Ingredient:doxycycline
Patents:0
Therapeutic Class:Antibacterials
Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 205115
Ingredient-typeTetracyclines
Medical Subject Heading (MeSH) Categories for 205115
Suppliers and Packaging for NDA: 205115
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE doxycycline CAPSULE;ORAL 205115 ANDA Proficient Rx LP 63187-712 N 63187-712-14
DOXYCYCLINE doxycycline CAPSULE;ORAL 205115 ANDA Proficient Rx LP 63187-712 N 63187-712-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Feb 18, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Feb 18, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Feb 18, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Daiichi Sankyo
McKinsey
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Cipla
Queensland Health
Express Scripts
QuintilesIMS
McKesson

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