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Last Updated: April 22, 2025

Details for New Drug Application (NDA): 217170

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NDA 217170 describes DOXYCYCLINE, which is a drug marketed by Alembic, Apotex, Cosette, Dr Reddys, Dr Reddys Labs Sa, Impax Labs Inc, Lupin, Lupin Ltd, Prinston Inc, Rising, Sandoz Inc, Strides Pharma, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell, Hikma, Mylan Labs Ltd, Heritage, Lannett Co Inc, Somerset Theraps Llc, Sun Pharm Industries, Pliva, Bausch, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Changzhou Pharm, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Nostrum Labs Inc, Par Pharm, Pvt Form, Ranbaxy, Superpharm, Warner Chilcott, Zhejiang Yongtai, Zydus Lifesciences, Amneal, Endo Operations, Gland Pharma Ltd, Kindos, Precision Dose Inc, Slate Run Pharma, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Acella, Amneal Pharms Co, Avet Lifesciences, Chartwell Molecular, Epic Pharma Llc, Heritage Pharma, Larken Labs, Mylan, Novel Labs Inc, Oryza, Praxgen, and Torrent, and is included in one hundred and sixteen NDAs. It is available from thirty-four suppliers. Additional details are available on the DOXYCYCLINE profile page.

The generic ingredient in DOXYCYCLINE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-five suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

Summary for 217170

Tradename:	DOXYCYCLINE
Applicant:	Apotex
Ingredient:	doxycycline
Patents:	0

Pharmacology for NDA: 217170

Medical Subject Heading (MeSH) Categories for 217170

Anti-Bacterial Agents
Antimalarials

Suppliers and Packaging for NDA: 217170

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXYCYCLINE	doxycycline	CAPSULE;ORAL	217170	ANDA	Apotex Corp.	60505-4775	60505-4775-3	30 CAPSULE in 1 BOTTLE (60505-4775-3)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	40MG
Approval Date:	Jul 11, 2024	TE:	AB	RLD:	No

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