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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 084754

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NDA 084754 describes DEXAMETHASONE, which is a drug marketed by Alpharma Us Pharms, Lyne, Sti Pharma Llc, Vintage Pharms, Wockhardt Eu Operatn, Abraxis Pharm, Fresenius Kabi Usa, West-ward Pharms Int, Watson Labs, ECR, 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 084754

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 084754

Suppliers and Packaging for NDA: 084754

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXAMETHASONE dexamethasone ELIXIR;ORAL 084754 ANDA STI Pharma LLC 54879-003 54879-003-08 237 mL in 1 BOTTLE, GLASS (54879-003-08)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:ELIXIR;ORALStrength0.5MG/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

Argus Health
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Healthtrust
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Citi
Harvard Business School
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Deloitte
Johnson and Johnson
UBS

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