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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 090891


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NDA 090891 describes DEXAMETHASONE, which is a drug marketed by Alpharma Us Pharms, Anima, Chartwell Molecular, Lyne, Pharmobedient Cnsltg, Abraxis Pharm, Fresenius Kabi Usa, Hikma, Watson Labs, Alvogen, Amneal, Apotex, Bausch, Bionpharma, Chartwell Rx, Impax Labs, Larken Labs Inc, Novitium Pharma, Pangea, Phoenix Labs Ny, Prasco, Pvt Form, Roxane, Sun Pharm Industries, Upsher Smith, Whiteworth Town Plsn, Xspire Pharma, Zydus Pharms, Watson Labs Teva, Bel Mar, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Geneyork Pharms, Gland Pharma Ltd, Intl Medication, Luitpold, Lyphomed, Mylan Labs Ltd, Somerset, Somerset Theraps Llc, Teva Parenteral, West-ward Pharms Int, Wyeth Ayerst, Sola Barnes Hind, Bausch And Lomb, and Sandoz, and is included in ninety-six NDAs. It is available from thirty-five 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 090891
Tradename:DEXAMETHASONE
Applicant:Lyne
Ingredient:dexamethasone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090891
Medical Subject Heading (MeSH) Categories for 090891
Suppliers and Packaging for NDA: 090891
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXAMETHASONE dexamethasone ELIXIR;ORAL 090891 ANDA Rising Pharma Holdings, Inc. 64980-509 64980-509-24 237 mL in 1 BOTTLE, PLASTIC (64980-509-24)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:ELIXIR;ORALStrength0.5MG/5ML
Approval Date:Jul 12, 2011TE:AARLD:No

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