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Generated: December 9, 2018

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Details for New Drug Application (NDA): 084752

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NDA 084752 describes DEXAMETHASONE SODIUM PHOSPHATE, which is a drug marketed by Akorn, Amneal Pharms Co, Aurobindo Pharma Ltd, Bel Mar, Dell Labs, Fresenius Kabi Usa, Intl Medication, Luitpold, Lyphomed, Mylan Labs Ltd, Somerset Theraps Llc, Teva Parenteral, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Sola Barnes Hind, Bausch And Lomb, and Sandoz Inc, and is included in thirty-three NDAs. It is available from twenty 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. Twenty-three suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.
Summary for 084752
Tradename:DEXAMETHASONE SODIUM PHOSPHATE
Applicant:Bel Mar
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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Serving hundreds of leading biopharmaceutical companies globally:

Covington
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Mallinckrodt
Daiichi Sankyo
Moodys
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Accenture
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