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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 207494

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NDA 207494 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, 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, Dr Reddys, Gland, Heritage, Kindos, Lupin Ltd, Ph Health, Precision Dose Inc, Slate Run Pharma, Steriscience, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Impax Labs Inc, Lupin, Prinston Inc, Rising, Zydus Pharms, Acella, Amneal Pharms Co, Apotex, Avet Lifesciences, Chartwell Molecular, Dr Reddys Labs Sa, Epic Pharma Llc, Heritage Pharma, Mylan, Novel Labs Inc, Pharmobedient, Praxgen, Strides Pharma Intl, and Torrent, and is included in eighty-seven NDAs. It is available from sixty-nine 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-seven suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

Summary for 207494

Tradename:	DOXYCYCLINE HYCLATE
Applicant:	Prinston Inc
Ingredient:	doxycycline hyclate
Patents:	0

Pharmacology for NDA: 207494

Suppliers and Packaging for NDA: 207494

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	207494	ANDA	Solco Healthcare US LLC	43547-324	43547-324-06	60 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-324-06)
DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	207494	ANDA	Solco Healthcare US LLC	43547-324	43547-324-10	100 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-324-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Nov 15, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 200MG BASE
Approval Date:	Nov 15, 2016	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 50MG BASE
Approval Date:	Feb 19, 2019	TE:	AB	RLD:	No

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