Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Daiichi Sankyo
US Army
Mallinckrodt
Queensland Health
Chubb
Boehringer Ingelheim
Johnson and Johnson
Healthtrust

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040519

« Back to Dashboard

NDA 040519 describes DIMENHYDRINATE, which is a drug marketed by Baxter Hlthcare, Fresenius Kabi Usa, Watson Labs, Watson Labs Teva, Wyeth Ayerst, Alra, Heather, and Nexgen Pharma Inc, and is included in nine NDAs. It is available from one supplier. Additional details are available on the DIMENHYDRINATE profile page.

The generic ingredient in DIMENHYDRINATE is dimenhydrinate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dimenhydrinate profile page.
Summary for 040519
Tradename:DIMENHYDRINATE
Applicant:Fresenius Kabi Usa
Ingredient:dimenhydrinate
Patents:0
Therapeutic Class:Antiemetics
Respiratory Tract Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 040519
Suppliers and Packaging for NDA: 040519
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIMENHYDRINATE dimenhydrinate INJECTABLE;INJECTION 040519 ANDA APP Pharmaceuticals, LLC 63323-366 N 63323-366-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Jun 23, 2004TE:RLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Citi
Baxter
US Department of Justice
Mallinckrodt
QuintilesIMS
Medtronic
Covington
AstraZeneca

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.