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

Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 084612

« Back to Dashboard

NDA 084612 describes DEXAMETHASONE, which is a drug marketed by Alpharma Us Pharms, Lyne, Sti Pharma Llc, Vintage Pharms, Wockhardt Bio Ag, Abraxis Pharm, Fresenius Kabi Usa, West-ward Pharms Int, Watson Labs, ECR, Fera Pharms Llc, Idt Australia Ltd, Impax Labs, Larken Labs Inc, Par Pharm, Phoenix Labs Ny, Pvt Form, Roxane, Sun Pharm Industries, Upsher Smith, Whiteworth Town Plsn, Xspire Pharma, Watson Labs Teva, Akorn, Aurobindo Pharma Ltd, Bel Mar, Dell Labs, Intl Medication, Luitpold, Lyphomed, Mylan Labs Ltd, Teva Parenteral, Wyeth Ayerst, Sola Barnes Hind, Bausch And Lomb, and Sandoz Inc, and is included in seventy-eight NDAs. It is available from thirty-three suppliers. Additional details are available on the DEXAMETHASONE profile page.

The generic ingredient in DEXAMETHASONE is dexamethasone acetate. There are thirty-nine drug master file entries for this compound. Additional details are available on the dexamethasone acetate profile page.

Summary for 084612

Tradename:	DEXAMETHASONE
Applicant:	West-ward Pharms Int
Ingredient:	dexamethasone
Patents:	0
Therapeutic Class:	Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal) Inflammatory Bowel Disease Agents Ophthalmic Agents
Formulation / Manufacturing:	see details

Pharmacology for NDA: 084612

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 084612

Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents, Hormonal
Glucocorticoids

Suppliers and Packaging for NDA: 084612

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXAMETHASONE	dexamethasone	TABLET;ORAL	084612	ANDA	West-Ward Pharmaceuticals Corp.	0054-4184	N	0054-4184-25
DEXAMETHASONE	dexamethasone	TABLET;ORAL	084612	ANDA	West-Ward Pharmaceuticals Corp.	0054-8175	N	0054-8175-25

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	BP	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:

Argus Health

Chubb

Accenture

Colorcon

Queensland Health

McKesson

Baxter

Merck

Teva

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.