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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 088638

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NDA 088638 describes ACETIC ACID, which is a drug marketed by Chartwell Rx, Kv Pharm, Rising, Sciegen Pharms Inc, Sun Pharma Canada, B Braun, Baxter Hlthcare, Otsuka Icu Medcl, and Bausch And Lomb, and is included in ten NDAs. It is available from four suppliers. Additional details are available on the ACETIC ACID profile page.

The generic ingredient in ACETIC ACID is acetic acid, glacial; hydrocortisone. There are thirty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the acetic acid, glacial; hydrocortisone profile page.

Summary for 088638

Tradename:	ACETIC ACID
Applicant:	Sun Pharma Canada
Ingredient:	acetic acid, glacial
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OTIC			Strength	2%
Approval Date:	Sep 6, 1984	TE:		RLD:	No

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