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Generated: November 13, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040166

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NDA 040166 describes ACETIC ACID, which is a drug marketed by Anda Repository, Kv Pharm, Lannett Co Inc, 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. Four suppliers are listed for this compound. Additional details are available on the acetic acid, glacial; hydrocortisone profile page.
Summary for 040166
Applicant:Wockhardt Bio Ag
Ingredient:acetic acid, glacial
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 040166
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETIC ACID acetic acid, glacial SOLUTION/DROPS;OTIC 040166 ANDA Unit Dose Services 50436-4600 50436-4600-1 15 mL in 1 BOTTLE (50436-4600-1)
ACETIC ACID acetic acid, glacial SOLUTION/DROPS;OTIC 040166 ANDA Morton Grove Pharmaceuticals, Inc. 60432-741 60432-741-15 15 mL in 1 BOTTLE, PLASTIC (60432-741-15)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OTICStrength2%
Approval Date:Jul 26, 1996TE:ATRLD:No

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