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Last Updated: April 19, 2024

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

Tradename:	DIMENHYDRINATE
Applicant:	Fresenius Kabi Usa
Ingredient:	dimenhydrinate
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 040519

Antiemetics
Histamine H1 Antagonists

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	Fresenius Kabi USA, LLC	63323-366	63323-366-01	25 VIAL in 1 TRAY (63323-366-01) / 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Jun 23, 2004	TE:		RLD:	No

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