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Last Updated: June 16, 2021

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Details for New Drug Application (NDA): 040700

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NDA 040700 describes DEXAMETHASONE, which is a drug marketed by Alpharma Us Pharms, Anima, Lannett Co Inc, Lyne, Wockhardt Bio Ag, Abraxis Pharm, Fresenius Kabi Usa, Hikma, Watson Labs, Ani Pharms Inc, ECR, Fera Pharms Llc, Heritage Pharma, 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, Amneal, Aurobindo Pharma Ltd, Bel Mar, Dell Labs, Dr Reddys, 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 Inc, and is included in eighty-three NDAs. It is available from twenty-seven 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 040700
Formulation / Manufacturing:see details
Pharmacology for NDA: 040700
Medical Subject Heading (MeSH) Categories for 040700
Suppliers and Packaging for NDA: 040700
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXAMETHASONE dexamethasone TABLET;ORAL 040700 ANDA Bausch Health US LLC 0095-0087 0095-0087-35 35 TABLET in 1 BLISTER PACK (0095-0087-35)
DEXAMETHASONE dexamethasone TABLET;ORAL 040700 ANDA Bausch Health US LLC 0095-0088 0095-0088-51 51 TABLET in 1 BLISTER PACK (0095-0088-51)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.5MG
Approval Date:Aug 15, 2008TE:ABRLD:No

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