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

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 217000


✉ Email this page to a colleague

« Back to Dashboard


NDA 217000 describes DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Bionpharma, Mylan Pharms Inc, and Ph Health, and is included in five NDAs. It is available from five suppliers. Additional details are available on the DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE profile page.

The generic ingredient in DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.
Summary for 217000
Tradename:DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Applicant:Bionpharma
Ingredient:doxylamine succinate; pyridoxine hydrochloride
Patents:0
Pharmacology for NDA: 217000
Ingredient-typeAnalogs/Derivatives
Vitamin B 6
Mechanism of ActionHistamine Receptor Antagonists
Suppliers and Packaging for NDA: 217000
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE doxylamine succinate; pyridoxine hydrochloride TABLET, DELAYED RELEASE;ORAL 217000 ANDA Bionpharma Inc., 69452-206 69452-206-20 100 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-206-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength10MG;10MG
Approval Date:Aug 4, 2023TE: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. 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.

 
© Copyright 2002-2025 thinkBiotech LLC
ISSN: 2162-2639
Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2025 - 2026
 NCE-1 Patent Challenge Dates 2025 - 2026
Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
   See Primary Research Papers Citing DrugPatentWatch

Links