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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 210664

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NDA 210664 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 210664

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

Pharmacology for NDA: 210664

Suppliers and Packaging for NDA: 210664

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	210664	ANDA	Acella Pharmaceuticals, LLC	42192-501	42192-501-05	500 TABLET, COATED in 1 BOTTLE (42192-501-05)
DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	210664	ANDA	Acella Pharmaceuticals, LLC	42192-501	42192-501-50	50 TABLET, COATED in 1 BOTTLE (42192-501-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Mar 16, 2020	TE:	AB	RLD:	No

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