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Last Updated: April 22, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088481

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NDA 088481 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 088481
Tradename:DEXAMETHASONE
Applicant:Fera Pharms Llc
Ingredient:dexamethasone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 088481
Medical Subject Heading (MeSH) Categories for 088481
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 Fera Pharmaceuticals, LLC 48102-045 48102-045-01 100 TABLET in 1 BOTTLE (48102-045-01)
DEXAMETHASONE dexamethasone TABLET;ORAL 088481 ANDA Fera Pharmaceuticals, LLC 48102-046 48102-046-01 100 TABLET in 1 BOTTLE (48102-046-01)

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Apr 28, 1983TE:BPRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.75MG
Approval Date:Apr 28, 1983TE:BPRLD:No

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