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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 090431

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NDA 090431 describes DOXYCYCLINE HYCLATE, which is a drug marketed by Pliva, Bausch, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms, Changzhou Pharm, Chartwell, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Nostrum Labs Inc, Par Pharm, Pvt Form, Ranbaxy, Strides Pharma, Sun Pharm Industries, Superpharm, Warner Chilcott, Watson Labs, Zhejiang Yongtai, Zydus Lifesciences, Endo Operations, Gland Pharma Ltd, Heritage, Kindos, Lupin Ltd, Slate Run Pharma, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Impax Labs Inc, Lupin, Prinston Inc, Rising, Zydus Pharms, Acella, Amneal, Amneal Pharms Co, Apotex, Avet Lifesciences, Chartwell Molecular, Dr Reddys Labs Sa, Epic Pharma Llc, Heritage Pharma, Larken Labs, Mylan, Novel Labs Inc, Oryza, Praxgen, and Torrent, and is included in eighty-two NDAs. It is available from sixty-six suppliers. Additional details are available on the DOXYCYCLINE HYCLATE profile page.

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

Summary for 090431

Tradename:	DOXYCYCLINE HYCLATE
Applicant:	Rising
Ingredient:	doxycycline hyclate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 75MG BASE
Approval Date:	Dec 28, 2010	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 100MG BASE
Approval Date:	Dec 28, 2010	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 50MG BASE
Approval Date:	May 23, 2016	TE:		RLD:	No

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