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Serving hundreds of leading biopharmaceutical companies globally:

US Army
US Department of Justice
Daiichi Sankyo

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040519

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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
Applicant:Fresenius Kabi Usa
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

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Chinese Patent Office
Daiichi Sankyo
Johnson and Johnson

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