Last Updated: August 9, 2026

Details for New Drug Application (NDA): 211418

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NDA 211418 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, Macleods Pharms Ltd, 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, Avet Lifesciences, Dr Reddys, Gland, Heritage, Kindos, Lupin, Ph Health, Pharmobedient, Slate Run Pharma, Steriscience, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Impax Labs Inc, Prinston Inc, Rising, Zydus Pharms, Acella, Amneal Pharms Co, Apotex, Chartwell Molecular, Dr Reddys Labs Sa, Epic Pharma Llc, Heritage Pharma, Mylan, Novel Labs Inc, Oryza, Praxgen, Strides Pharma Intl, and Torrent, and is included in ninety NDAs. It is available from seventy 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 211418

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

Pharmacology for NDA: 211418

Suppliers and Packaging for NDA: 211418

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	211418	ANDA	Macleods Pharmaceuticals Limited	33342-392	33342-392-05	20 TABLET in 1 BOTTLE (33342-392-05)
DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	211418	ANDA	Macleods Pharmaceuticals Limited	33342-392	33342-392-08	50 TABLET in 1 BOTTLE (33342-392-08)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Nov 19, 2025	TE:	AB	RLD:	No

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