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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Argus Health
Johnson and Johnson
Federal Trade Commission

Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088160

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NDA 088160 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, Watson Labs Teva, 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 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: 088160

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 088160

Suppliers and Packaging for NDA: 088160

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 088160 ANDA Par Pharmaceutical Inc. 49884-085 49884-085-01 100 TABLET in 1 BOTTLE, PLASTIC (49884-085-01)
TABLET;ORAL 088160 ANDA H.J. Harkins Company, Inc. 52959-392 52959-392-12 12 TABLET in 1 BOTTLE, PLASTIC (52959-392-12)

Summary for product number 001

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

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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Farmers Insurance
Daiichi Sankyo
Federal Trade Commission

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