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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 050612

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NDA 050612 describes PRED-G, which is a drug marketed by Allergan and is included in two NDAs. Additional details are available on the PRED-G profile page.

The generic ingredient in PRED-G is gentamicin sulfate; prednisolone acetate. There are fifteen drug master file entries for this compound. Additional details are available on the gentamicin sulfate; prednisolone acetate profile page.

Summary for 050612

Tradename:	PRED-G
Applicant:	Allergan
Ingredient:	gentamicin sulfate; prednisolone acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	OINTMENT;OPHTHALMIC			Strength	EQ 0.3% BASE;0.6%
Approval Date:	Dec 1, 1989	TE:		RLD:	Yes

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