Last Updated: November 8, 2026

Details for New Drug Application (NDA): 084169

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NDA 084169 describes PREDNISOLONE SODIUM PHOSPHATE, which is a drug marketed by Watson Labs, Alcon Pharms Ltd, Bausch And Lomb, Bausch And Lomb Inc, Epic Pharma Llc, Sola Barnes Hind, Amneal, Amneal Pharms, Bausch, Chartwell Rx, Edenbridge Pharms, Hikma, Mission Pharma, Nesher Pharms, Ph Health, Pharm Assoc, Pharmobedient, Pharmobedient Cnsltg, Vintage Pharms, We Pharms, and Rising, and is included in thirty NDAs. It is available from fifteen suppliers. Additional details are available on the PREDNISOLONE SODIUM PHOSPHATE profile page.

The generic ingredient in PREDNISOLONE SODIUM PHOSPHATE is prednisolone sodium phosphate. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.

Summary for 084169

Tradename:	PREDNISOLONE SODIUM PHOSPHATE
Applicant:	Sola Barnes Hind
Ingredient:	prednisolone sodium phosphate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.9% PHOSPHATE
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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