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Details for New Drug Application (NDA): 084081

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NDA 084081 describes DEXAMETHASONE, which is a drug marketed by ECR, Phoenix Labs Ny, Roxane, Sun Pharm Inds, 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, Eurohlth Intl Sarl, Mylan Labs Ltd, Intl Medication, Teva Parenteral, Luitpold, Wyeth Ayerst, Bel Mar, Akorn, Dell Labs, Lyphomed, Bausch And Lomb, Sola Barnes Hind, Alcon Pharms Ltd, and Aurobindo Pharma Ltd, and is included in seventy-seven NDAs. It is available from twenty-six suppliers. Additional details are available on the DEXAMETHASONE profile page.

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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.75MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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