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Generated: August 20, 2018

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Details for New Drug Application (NDA): 065053

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NDA 065053 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-nine 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 065053
Tradename:DOXYCYCLINE
Applicant:Sun Pharm Inds Ltd
Ingredient:doxycycline
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065053
Ingredient-typeTetracyclines
Medical Subject Heading (MeSH) Categories for 065053
Suppliers and Packaging for NDA: 065053
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE doxycycline CAPSULE;ORAL 065053 ANDA Sun Pharmaceutical Industries, Inc. 63304-614 N 63304-614-01
DOXYCYCLINE doxycycline CAPSULE;ORAL 065053 ANDA Sun Pharmaceutical Industries, Inc. 63304-614 N 63304-614-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Nov 22, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Nov 22, 2000TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Sep 10, 2003TE:ABRLD:No

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