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Last Updated: April 17, 2021

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Details for New Drug Application (NDA): 205115

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NDA 205115 describes DOXYCYCLINE, which is a drug marketed by Alembic Pharms Ltd, Cosette, Impax Labs Inc, Lupin Ltd, Mayne Pharma Inc, Mylan Pharms Inc, Par Pharm, Sandoz Inc, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, 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, Ajanta Pharma Ltd, Amneal Pharms, Changzhou Pharm, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nostrum Labs Inc, Pvt Form, Ranbaxy, Superpharm, Warner Chilcott, Zhejiang Yongtai, Actavis Elizabeth, Prinston Inc, Acella, Amneal Pharms Co, Apotex, Cadila, Caribe Holdings, Emcure Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Larken Labs, Novel Labs Inc, and Vintage Pharms, and is included in ninety-four NDAs. It is available from thirty-seven suppliers. Additional details are available on the DOXYCYCLINE profile page.

The generic ingredient in DOXYCYCLINE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-five suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 205115
Tradename:DOXYCYCLINE
Applicant:Zydus Pharms
Ingredient:doxycycline
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205115
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 A-S Medication Solutions 50090-4833 50090-4833-0 20 CAPSULE in 1 BOTTLE (50090-4833-0)
DOXYCYCLINE doxycycline CAPSULE;ORAL 205115 ANDA A-S Medication Solutions 50090-4833 50090-4833-1 14 CAPSULE in 1 BOTTLE (50090-4833-1)

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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