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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 209165

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NDA 209165 describes DOXYCYCLINE, which is a drug marketed by Alembic, Apotex, Changzhou Pharm, Cosette, Dr Reddys, Dr Reddys Labs Sa, Impax Labs Inc, Lupin, Lupin Ltd, Macleods Pharms Ltd, Prinston Inc, Rising, Sandoz Inc, Strides Pharma, Strides Pharma Intl, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell, Hikma, Mylan Labs Ltd, Chartwell Rx, Heritage, Lannett Co Inc, Sun Pharm Industries, Pliva, Bausch, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Bionpharma, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Par Pharm, Pvt Form, Ranbaxy, Superpharm, Warner Chilcott, Zhejiang Yongtai, Zydus Lifesciences, Amneal, Aspiro, Gland, Kindos, Ph Health, Precision Dose Inc, Slate Run Pharma, Steriscience, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Acella, Amneal Pharms Co, Avet Lifesciences, Chartwell Molecular, Epic Pharma Llc, Heritage Pharma, Mylan, Novel Labs Inc, Pharmobedient, Praxgen, and Torrent, and is included in one hundred and twenty-one NDAs. It is available from thirty-six 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-seven suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

Summary for 209165

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

Pharmacology for NDA: 209165

Medical Subject Heading (MeSH) Categories for 209165

Anti-Bacterial Agents
Antimalarials

Suppliers and Packaging for NDA: 209165

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXYCYCLINE	doxycycline	CAPSULE;ORAL	209165	ANDA	Alembic Pharmaceuticals Limited	46708-249	46708-249-30	30 CAPSULE in 1 BOTTLE (46708-249-30)
DOXYCYCLINE	doxycycline	CAPSULE;ORAL	209165	ANDA	Alembic Pharmaceuticals Limited	46708-249	46708-249-31	100 CAPSULE in 1 BOTTLE (46708-249-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 75MG BASE
Approval Date:	Jul 28, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 100MG BASE
Approval Date:	Jul 28, 2017	TE:	AB	RLD:	No

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