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Generated: June 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 084612

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NDA 084612 describes DEXAMETHASONE, which is a drug marketed by ECR, Phoenix Labs Ny, West-ward Pharms Int, Sun Pharm Inds, Roxane, Watson Labs, Pvt Form, Whiteworth Town Plsn, Upsher Smith, Par Pharm, Abraxis Pharm, Sti Pharma Llc, Wockhardt Eu Operatn, Fresenius Kabi Usa, Impax Labs, Vintage Pharms, Lyne, Alpharma Us Pharms, Idt Australia Ltd, Watson Labs Teva, Mylan Labs Ltd, Intl Medication, Teva Parenteral, Luitpold, Wyeth Ayerst, Bel Mar, Akorn, Dell Labs, Lyphomed, Bausch And Lomb, Sola Barnes Hind, Sandoz Inc, and Aurobindo Pharma Ltd, and is included in seventy-seven NDAs. It is available from thirty 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 NDA: 084612

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 084612

Mechanism of ActionCorticosteroid Hormone Receptor Agonists

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 0054-4184-25 100 TABLET in 1 BOTTLE, PLASTIC (0054-4184-25)
DEXAMETHASONE
dexamethasone
 TABLET;ORAL 084612 ANDA West-Ward Pharmaceuticals Corp. 0054-8175 0054-8175-25 10 BLISTER PACK in 1 CARTON (0054-8175-25) > 10 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Approved Prior to Jan 1, 1982TE:BPRLD:No


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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Moodys
Accenture
Colorcon
Medtronic
Express Scripts
US Army
McKesson
Chubb
Merck

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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