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Generated: May 29, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040607

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NDA 040607 describes ACETIC ACID, which is a drug marketed by Vintage, Taro, Wockhardt, Kv Pharm, Baxter Hlthcare, Icu Medcl, B Braun, and Bausch And Lomb, and is included in nine 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-five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the acetic acid, glacial; hydrocortisone profile page.

Summary for NDA: 040607

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, glacial
SOLUTION/DROPS;OTIC 040607 ANDA Qualitest Pharmaceuticals 0603-7038 0603-7038-41 15 mL in 1 BOTTLE (0603-7038-41)
acetic acid, glacial
SOLUTION/DROPS;OTIC 040607 ANDA Qualitest Pharmaceuticals 0603-7038 0603-7038-45 30 mL in 1 BOTTLE (0603-7038-45)

Summary for product number 001

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

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