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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 084855

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NDA 084855 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, Micro Labs, Mylan Labs Ltd, Somerset, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Wyeth Ayerst, Sola Barnes Hind, Bausch And Lomb, and Sandoz, and is included in forty NDAs. It is available from eighteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.

Summary for 084855

Tradename:	DEXAMETHASONE SODIUM PHOSPHATE
Applicant:	Epic Pharma Llc
Ingredient:	dexamethasone sodium phosphate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OTIC			Strength	EQ 0.1% PHOSPHATE
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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