Last Updated: June 17, 2026

Details for New Drug Application (NDA): 216631

✉ Email this page to a colleague

« Back to Dashboard

NDA 216631 describes DOXYCYCLINE, which is a drug marketed by Aiping Pharm Inc, Alembic, Apotex, Cosette, Dr Reddys, Dr Reddys Labs Sa, Impax Labs Inc, Lupin, Macleods Pharms Ltd, 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, 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-four suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

Summary for 216631

Tradename:	DOXYCYCLINE
Applicant:	Lupin
Ingredient:	doxycycline
Patents:	0

Pharmacology for NDA: 216631

Medical Subject Heading (MeSH) Categories for 216631

Anti-Bacterial Agents
Antimalarials

Suppliers and Packaging for NDA: 216631

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXYCYCLINE	doxycycline	CAPSULE;ORAL	216631	ANDA	Lupin Pharmaceuticals, Inc.	70748-308	70748-308-06	30 CAPSULE in 1 BOTTLE (70748-308-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	40MG
Approval Date:	Apr 8, 2024	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.