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Generated: May 30, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088481

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NDA 088481 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, 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-one 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: 088481

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: 088481

Mechanism of ActionCorticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 088481

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXAMETHASONE
dexamethasone
 TABLET;ORAL 088481 ANDA Par Pharmaceutical Inc. 49884-373 49884-373-01 100 TABLET in 1 BOTTLE, PLASTIC (49884-373-01)
DEXAMETHASONE
dexamethasone
 TABLET;ORAL 088481 ANDA Integrated Pharma Solutions Llc 61219-996 61219-996-21 1 KIT in 1 CARTON (61219-996-21) * 2 TABLET in 1 BOTTLE, PLASTIC (61219-084-02) * 3 mL in 1 PACKET (61219-374-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength6MG
Approval Date:Nov 28, 1983TE:BPRLD:No


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