Last Updated: September 28, 2026

Details for New Drug Application (NDA): 091052

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NDA 091052 describes DOXYCYCLINE HYCLATE, which is a drug marketed by Pliva, Bausch, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms, Bionpharma, Changzhou Pharm, Chartwell, Halsey, Heather, Hikma Intl Pharms, Interpharm, Macleods Pharms, Mutual Pharm, Nesher Pharms, Par Pharm, Pvt Form, Ranbaxy, Strides Pharma, Sun Pharm Industries, Superpharm, Warner Chilcott, Watson Labs, Zhejiang Yongtai, Zydus Lifesciences, Amneal, Aspiro, Avet Lifesciences, Dr Reddys, Gland, Hainan Poly, Heritage, Kindos, Lupin, Ph Health, Pharmobedient, Steriscience, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Impax Labs Inc, Prinston Inc, Rising, Zydus Pharms, Acella, Amneal Pharms Co, Apotex, Arthur Grp, Chartwell Molecular, Dr Reddys Labs Sa, Epic Pharma Llc, Heritage Pharma, Mylan, Novel Labs Inc, Oryza, Strides Pharma Intl, and Torrent, and is included in ninety NDAs. It is available from seventy suppliers. Additional details are available on the DOXYCYCLINE HYCLATE profile page.

The generic ingredient in DOXYCYCLINE HYCLATE is doxycycline hyclate. There is one drug master file entry for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

Summary for 091052

Tradename:	DOXYCYCLINE HYCLATE
Applicant:	Aurobindo Pharma Usa
Ingredient:	doxycycline hyclate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Feb 8, 2012	TE:		RLD:	No

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