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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 065471

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NDA 065471 describes DOXYCYCLINE, which is a drug marketed by Alembic, Apotex, Changzhou Pharm, Cosette, Dr Reddys, Dr Reddys Labs Sa, Impax Labs Inc, Lupin, Lupin Ltd, Macleods Pharms Ltd, Prinston Inc, Rising, Sandoz Inc, Strides Pharma, Strides Pharma Intl, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell, Hikma, Mylan Labs Ltd, Chartwell Rx, Heritage, Lannett Co Inc, Sun Pharm Industries, Pliva, Bausch, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Bionpharma, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Par Pharm, Pvt Form, Ranbaxy, Superpharm, Warner Chilcott, Zhejiang Yongtai, Zydus Lifesciences, Amneal, Aspiro, Gland, Kindos, Ph Health, Precision Dose Inc, Slate Run Pharma, Steriscience, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Acella, Amneal Pharms Co, Avet Lifesciences, Chartwell Molecular, Epic Pharma Llc, Heritage Pharma, Mylan, Novel Labs Inc, Pharmobedient, Praxgen, and Torrent, and is included in one hundred and twenty-one NDAs. It is available from thirty-six 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-seven suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

Summary for 065471

Tradename:	DOXYCYCLINE
Applicant:	Sun Pharm Industries
Ingredient:	doxycycline
Patents:	0

Medical Subject Heading (MeSH) Categories for 065471

Anti-Bacterial Agents
Antimalarials

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 50MG BASE
Approval Date:	Apr 17, 2009	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 75MG BASE
Approval Date:	Apr 17, 2009	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Apr 17, 2009	TE:		RLD:	No

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