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Serving 500+ biopharmaceutical companies globally:

Citi
Medtronic
Moodys
Baxter
Covington
Express Scripts
AstraZeneca
Johnson and Johnson
Federal Trade Commission
Boehringer Ingelheim

Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021876

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NDA 021876 describes DICLEGIS, which is a drug marketed by Duchesnay and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DICLEGIS profile page.

The generic ingredient in DICLEGIS is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.

Summary for NDA: 021876

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 021876

Suppliers and Packaging for NDA: 021876

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLEGIS
doxylamine succinate; pyridoxine hydrochloride
TABLET, DELAYED RELEASE;ORAL 021876 NDA Duchesnay USA, Inc. 55494-100 55494-100-10 100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10)
DICLEGIS
doxylamine succinate; pyridoxine hydrochloride
TABLET, DELAYED RELEASE;ORAL 021876 NDA Duchesnay USA, Inc. 55494-100 55494-100-99 12 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength10MG;10MG
Approval Date:Apr 8, 2013TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Jan 25, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Jun 21, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT


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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Mallinckrodt
Harvard Business School
Express Scripts
Merck
Moodys
Julphar
US Department of Justice
McKinsey
Cantor Fitzgerald

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 verifification 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.

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