You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 21, 2024

Details for New Drug Application (NDA): 065095


✉ Email this page to a colleague

« Back to Dashboard


NDA 065095 describes DOXYCYCLINE HYCLATE, which is a drug marketed by Pliva, Bausch, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms, Changzhou Pharm, Chartwell, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Nostrum Labs Inc, Par Pharm, Pvt Form, Ranbaxy, Strides Pharma, Sun Pharm Industries, Superpharm, Warner Chilcott, Watson Labs, Zhejiang Yongtai, Zydus Lifesciences, Endo Operations, Gland Pharma Ltd, Heritage, Lupin Ltd, Slate Run Pharma, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Impax Labs Inc, Lupin, Prinston Inc, Rising, Zydus Pharms, Acella, Amneal, Amneal Pharms Co, Apotex, Avet Lifesciences, Caribe Holdings, Chartwell Molecular, Dr Reddys Labs Sa, Epic Pharma Llc, Heritage Pharma, Larken Labs, Mylan, Novel Labs Inc, Oryza, Praxgen, and Torrent, and is included in eighty-one NDAs. It is available from sixty-five 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-four suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 065095
Tradename:DOXYCYCLINE HYCLATE
Applicant:Hikma Intl Pharms
Ingredient:doxycycline hyclate
Patents:0
Pharmacology for NDA: 065095
Suppliers and Packaging for NDA: 065095
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 065095 ANDA Hikma Pharmaceuticals USA Inc. 0143-2112 0143-2112-05 500 TABLET, COATED in 1 BOTTLE (0143-2112-05)
DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 065095 ANDA Hikma Pharmaceuticals USA Inc. 0143-2112 0143-2112-50 50 TABLET, COATED in 1 BOTTLE (0143-2112-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Jul 2, 2003TE:ABRLD: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. 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.