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Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087143

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NDA 087143 describes ACETASOL HC, which is a drug marketed by Actavis Mid Atlantic and is included in one NDA. It is available from one supplier. Additional details are available on the ACETASOL HC profile page.

The generic ingredient in ACETASOL HC is acetic acid, glacial; hydrocortisone. There are thirty-five 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 087143
Tradename:ACETASOL HC
Applicant:Actavis Mid Atlantic
Ingredient:acetic acid, glacial; hydrocortisone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 087143
Suppliers and Packaging for NDA: 087143
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETASOL HC acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 087143 ANDA Actavis Pharma, Inc. 0472-0882 N 0472-0882-82
ACETASOL HC acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 087143 ANDA Actavis Pharma, Inc. 45963-412 N 45963-412-61

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OTICStrength2%;1%
Approval Date:Jan 13, 1982TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
US Army
McKinsey
Mallinckrodt
Fish and Richardson
QuintilesIMS
Healthtrust
Cerilliant
Federal Trade Commission

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