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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 218888

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NDA 218888 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, Dr Reddys, Gland, Heritage, Kindos, Lupin Ltd, Ph Health, Precision Dose Inc, Slate Run Pharma, Steriscience, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Impax Labs Inc, Lupin, Prinston Inc, Rising, Zydus Pharms, Acella, Amneal Pharms Co, Apotex, Avet Lifesciences, Chartwell Molecular, Dr Reddys Labs Sa, Epic Pharma Llc, Heritage Pharma, Mylan, Novel Labs Inc, Oryza, Pharmobedient, Praxgen, Strides Pharma Intl, and Torrent, and is included in eighty-nine NDAs. It is available from sixty-eight 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-six suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

Summary for 218888

Tradename:	DOXYCYCLINE HYCLATE
Applicant:	Aspiro
Ingredient:	doxycycline hyclate
Patents:	0

Pharmacology for NDA: 218888

Suppliers and Packaging for NDA: 218888

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXYCYCLINE HYCLATE	doxycycline hyclate	INJECTABLE;INJECTION	218888	ANDA	Camber Pharmaceuticals, Inc.	31722-371	31722-371-32	10 VIAL in 1 CARTON (31722-371-32) / 10 mL in 1 VIAL (31722-371-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 100MG BASE/VIAL
Approval Date:	Aug 5, 2025	TE:	AP	RLD:	No

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