You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 19, 2026

Details for New Drug Application (NDA): 211137

✉ Email this page to a colleague

« Back to Dashboard

NDA 211137 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 211137

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

Pharmacology for NDA: 211137

Suppliers and Packaging for NDA: 211137

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	211137	ANDA	Macleods Pharmaceuticals Limited	33342-386	33342-386-08	50 CAPSULE in 1 BOTTLE (33342-386-08)
DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	211137	ANDA	Macleods Pharmaceuticals Limited	33342-386	33342-386-12	10 BLISTER PACK in 1 CARTON (33342-386-12) / 10 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 100MG BASE
Approval Date:	Dec 9, 2025	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.