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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 078416

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NDA 078416 describes PREDNISOLONE SODIUM PHOSPHATE, which is a drug marketed by Watson Labs, Alcon Pharms Ltd, Bausch And Lomb, Epic Pharma Llc, Sola Barnes Hind, Amneal, Amneal Pharms, Bausch, Chartwell Rx, Edenbridge Pharms, Endo Operations, Hikma, Mission Pharma, Nesher Pharms, Pharm Assoc, Pharmobedient Cnsltg, Vintage Pharms, We Pharms, Xttrium Labs Inc, and Rising, and is included in thirty NDAs. It is available from eleven suppliers. Additional details are available on the PREDNISOLONE SODIUM PHOSPHATE profile page.

The generic ingredient in PREDNISOLONE SODIUM PHOSPHATE is prednisolone sodium phosphate. There are eighty-eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.

Summary for 078416

Tradename:	PREDNISOLONE SODIUM PHOSPHATE
Applicant:	Vintage Pharms
Ingredient:	prednisolone sodium phosphate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	EQ 5MG BASE/5ML
Approval Date:	Oct 31, 2007	TE:		RLD:	No

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