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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204446

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NDA 204446 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-four 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. Eighty suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 204446
Tradename:DOXYCYCLINE
Applicant:G And W Labs Inc
Ingredient:doxycycline
Patents:0
Therapeutic Class:Antibacterials
Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204446
Ingredient-typeTetracyclines
Medical Subject Heading (MeSH) Categories for 204446
Suppliers and Packaging for NDA: 204446
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE doxycycline CAPSULE;ORAL 204446 ANDA G&W Laboratories, Inc. 0713-0427 N 0713-0427-01
DOXYCYCLINE doxycycline CAPSULE;ORAL 204446 ANDA G&W Laboratories, Inc. 0713-0428 N 0713-0428-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:May 28, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:May 28, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:May 28, 2015TE:ABRLD:No

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