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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 083738

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NDA 083738 describes PREDNISOLONE ACETATE, which is a drug marketed by Bel Mar, Cent Pharms, Epic Pharma Llc, Watson Labs, and Lupin Ltd, and is included in ten NDAs. It is available from one supplier. Additional details are available on the PREDNISOLONE ACETATE profile page.

The generic ingredient in PREDNISOLONE ACETATE is prednisolone acetate. There are eighty-eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the prednisolone acetate profile page.

Summary for 083738

Tradename:	PREDNISOLONE ACETATE
Applicant:	Bel Mar
Ingredient:	prednisolone acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	25MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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