Last Updated: September 24, 2026

Details for New Drug Application (NDA): 080517

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NDA 080517 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 sixteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.

Summary for 080517

Tradename:	PREDNISOLONE SODIUM PHOSPHATE
Applicant:	Watson Labs
Ingredient:	prednisolone sodium phosphate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 20MG PHOSPHATE/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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