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Last Updated: December 29, 2025

Details for New Drug Application (NDA): 011028

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NDA 011028 describes HYDELTRASOL, which is a drug marketed by Merck and is included in two NDAs. Additional details are available on the HYDELTRASOL profile page.

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

Summary for 011028

Tradename:	HYDELTRASOL
Applicant:	Merck
Ingredient:	prednisolone sodium phosphate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	OINTMENT;OPHTHALMIC, OTIC			Strength	EQ 0.25% PHOSPHATE
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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