Last Updated: May 25, 2026

Details for New Drug Application (NDA): 210381

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NDA 210381 describes DOXYCYCLINE, which is a drug marketed by Aiping Pharm Inc, Alembic, Apotex, 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, Changzhou Pharm, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Par Pharm, Pvt Form, Ranbaxy, Superpharm, Warner Chilcott, Zhejiang Yongtai, Zydus Lifesciences, Amneal, Aspiro, Avet Lifesciences, Gland, Kindos, Ph Health, Precision Dose Inc, Slate Run Pharma, Steriscience, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Acella, Amneal Pharms Co, Chartwell Molecular, Epic Pharma Llc, Heritage Pharma, Mylan, Novel Labs Inc, Oryza, Pharmobedient, Praxgen, and Torrent, and is included in one hundred and twenty-four 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-five suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

Summary for 210381

Tradename:	DOXYCYCLINE
Applicant:	Macleods Pharms Ltd
Ingredient:	doxycycline
Patents:	0

Pharmacology for NDA: 210381

Medical Subject Heading (MeSH) Categories for 210381

Anti-Bacterial Agents
Antimalarials

Suppliers and Packaging for NDA: 210381

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXYCYCLINE	doxycycline	CAPSULE;ORAL	210381	ANDA	Macleods Pharmaceuticals Limited	33342-346	33342-346-07	30 CAPSULE in 1 BOTTLE (33342-346-07)
DOXYCYCLINE	doxycycline	CAPSULE;ORAL	210381	ANDA	Macleods Pharmaceuticals Limited	33342-346	33342-346-12	10 BLISTER PACK in 1 CARTON (33342-346-12) / 10 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	40MG
Approval Date:	Mar 27, 2025	TE:	AB	RLD:	No

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