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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 065095

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NDA 065095 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 065095

Tradename:	DOXYCYCLINE HYCLATE
Applicant:	Hikma Intl Pharms
Ingredient:	doxycycline hyclate
Patents:	0

Pharmacology for NDA: 065095

Suppliers and Packaging for NDA: 065095

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	065095	ANDA	Hikma Pharmaceuticals USA Inc.	0143-2112	0143-2112-05	500 TABLET, COATED in 1 BOTTLE (0143-2112-05)
DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	065095	ANDA	Hikma Pharmaceuticals USA Inc.	0143-2112	0143-2112-50	50 TABLET, COATED in 1 BOTTLE (0143-2112-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Jul 2, 2003	TE:	AB	RLD:	No

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