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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 062677

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NDA 062677 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 062677

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

Pharmacology for NDA: 062677

Suppliers and Packaging for NDA: 062677

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	062677	ANDA	AvPAK	50268-279	50268-279-15	50 BLISTER PACK in 1 BOX (50268-279-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-279-11)
DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	062677	ANDA	Sun Pharmaceutical Industries, Inc.	53489-120	53489-120-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-120-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Jul 10, 1986	TE:	AB	RLD:	No

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