Last Updated: September 24, 2026

Details for New Drug Application (NDA): 083362

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NDA 083362 describes PREDNISOLONE TEBUTATE, which is a drug marketed by Watson Labs and is included in one NDA. Additional details are available on the PREDNISOLONE TEBUTATE profile page.

The generic ingredient in PREDNISOLONE TEBUTATE is prednisolone tebutate. There is one drug master file entry for this compound. Additional details are available on the prednisolone tebutate profile page.

Summary for 083362

Tradename:	PREDNISOLONE TEBUTATE
Applicant:	Watson Labs
Ingredient:	prednisolone tebutate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	20MG/ML
Approval Date:	Feb 17, 1984	TE:		RLD:	No

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