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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 087065


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NDA 087065 describes DEXAMETHASONE SODIUM PHOSPHATE, which is a drug marketed by Amneal, Bel Mar, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Geneyork Pharms, Gland Pharma Ltd, Hikma, Intl Medication, Luitpold, Lyphomed, Mylan Labs Ltd, Somerset, Somerset Theraps Llc, Teva Parenteral, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Sola Barnes Hind, Bausch And Lomb, and Sandoz, and is included in forty NDAs. It is available from seventeen suppliers. Additional details are available on the DEXAMETHASONE SODIUM PHOSPHATE profile page.

The generic ingredient in DEXAMETHASONE SODIUM PHOSPHATE is dexamethasone sodium phosphate. There are thirty-nine drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.
Summary for 087065
Tradename:DEXAMETHASONE SODIUM PHOSPHATE
Applicant:Lyphomed
Ingredient:dexamethasone sodium phosphate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 4MG PHOSPHATE/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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