Last Updated: September 24, 2026

Details for New Drug Application (NDA): 091406

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NDA 091406 describes DOXYCYCLINE, which is a drug marketed by Aiping Pharm Inc, Alembic, Apotex, Cosette Pharms Nc, Dr Reddys, Dr Reddys Labs Sa, Impax Labs Inc, Lupin, Macleods Pharms, Prinston Inc, Rising, Sandoz Inc, Strides Pharma, Strides Pharma Intl, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell, Lupin Ltd, 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, Hainan Poly, Kindos, Ph Health, Pharmobedient, Steriscience, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Acella, Amneal Pharms Co, Arthur Grp, Chartwell Molecular, Epic Pharma Llc, Heritage Pharma, Mylan, Novel Labs Inc, Oryza, and Torrent, and is included in one hundred and twenty-four NDAs. It is available from thirty-seven suppliers. Additional details are available on the DOXYCYCLINE profile page.

The generic ingredient in DOXYCYCLINE is doxycycline hyclate. There are two 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 091406

Tradename:	DOXYCYCLINE
Applicant:	Mylan Labs Ltd
Ingredient:	doxycycline hyclate
Patents:	0

Pharmacology for NDA: 091406

Suppliers and Packaging for NDA: 091406

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXYCYCLINE	doxycycline hyclate	INJECTABLE;INJECTION	091406	ANDA	Henry Schein, Inc	0404-9855	0404-9855-99	1 PACKAGE in 1 BAG (0404-9855-99) / 10 mL in 1 PACKAGE
DOXYCYCLINE	doxycycline hyclate	INJECTABLE;INJECTION	091406	ANDA	Mylan Institutional LLC	67457-437	67457-437-10	10 VIAL in 1 CARTON (67457-437-10) / 10 mL in 1 VIAL (67457-437-00)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 100MG BASE/VIAL
Approval Date:	Aug 21, 2012	TE:	AP	RLD:	No

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