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Last Updated: December 11, 2024

Details for New Drug Application (NDA): 065353

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NDA 065353 describes DOXYCYCLINE, which is a drug marketed by Alembic, Apotex, Cosette, Dr Reddys, Dr Reddys Labs Sa, Impax Labs Inc, Lupin, Lupin Ltd, Rising, Sandoz Inc, Strides Pharma, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell, Hikma, Mylan Labs Ltd, Heritage, Lannett Co Inc, Somerset Theraps Llc, Sun Pharm Industries, Pliva, Bausch, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Changzhou Pharm, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Nostrum Labs Inc, Par Pharm, Pvt Form, Ranbaxy, Superpharm, Warner Chilcott, Zhejiang Yongtai, Zydus Lifesciences, Endo Operations, Gland Pharma Ltd, Kindos, Slate Run Pharma, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Prinston Inc, Acella, Amneal, Amneal Pharms Co, Avet Lifesciences, Chartwell Molecular, Epic Pharma Llc, Heritage Pharma, Larken Labs, Mylan, Novel Labs Inc, Oryza, Praxgen, and Torrent, and is included in one hundred and thirteen NDAs. It is available from forty-one 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 065353

Tradename:	DOXYCYCLINE
Applicant:	Sandoz Inc
Ingredient:	doxycycline
Patents:	0

Medical Subject Heading (MeSH) Categories for 065353

Anti-Bacterial Agents
Antimalarials

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 50MG BASE
Approval Date:	Nov 27, 2006	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 75MG BASE
Approval Date:	Nov 27, 2006	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Nov 27, 2006	TE:		RLD:	No

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