Last Updated: November 8, 2026

Details for New Drug Application (NDA): 065134

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NDA 065134 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, 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, Chartwell Molecular, Dr Reddys Labs Sa, Epic Pharma Llc, Heritage Pharma, Mylan, Novel Labs Inc, Quagen, 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 065134

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

Pharmacology for NDA: 065134

Suppliers and Packaging for NDA: 065134

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	065134	ANDA	Sun Pharmaceutical Industries, Inc.	53489-647	53489-647-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-01)
DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	065134	ANDA	Sun Pharmaceutical Industries, Inc.	53489-647	53489-647-03	250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	May 13, 2005	TE:	AB	RLD:	No

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