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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 040607

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NDA 040607 describes ACETIC ACID, which is a drug marketed by Kv Pharm, Rising, Saptalis Pharms, Taro, Wockhardt Bio Ag, B Braun, Baxter Hlthcare, Icu Medical Inc, and Bausch And Lomb, and is included in ten NDAs. It is available from three 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. Two suppliers are listed for this compound. Additional details are available on the acetic acid, glacial; hydrocortisone profile page.
Summary for 040607
Applicant:Saptalis Pharms
Ingredient:acetic acid, glacial
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 040607
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETIC ACID acetic acid, glacial SOLUTION/DROPS;OTIC 040607 ANDA TruPharma, LLC 52817-816 52817-816-15 1 BOTTLE in 1 CARTON (52817-816-15) > 15 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OTICStrength2%
Approval Date:Feb 24, 2005TE:ATRLD:No

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