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Details for New Drug Application (NDA): 040166

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NDA 040166 describes ACETIC ACID, which is a drug marketed by Vintage, Taro, Wockhardt, Kv Pharm, Baxter Hlthcare, Hospira, 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: 040166

Tradename:
ACETIC ACID
Applicant:
Wockhardt
Ingredient:
acetic acid, glacial
Patents:0
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OTICStrength2%
Approval Date:Jul 26, 1996TE:ATRLD:Yes


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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