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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
US Department of Justice
Queensland Health
Boehringer Ingelheim
Farmers Insurance
Daiichi Sankyo

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 012770

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NDA 012770 describes VOSOL HC, which is a drug marketed by Hi Tech Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the VOSOL HC profile page.

The generic ingredient in VOSOL 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 012770
Tradename:VOSOL HC
Applicant:Hi Tech Pharma
Ingredient:acetic acid, glacial; hydrocortisone
Formulation / Manufacturing:see details
Pharmacology for NDA: 012770
Suppliers and Packaging for NDA: 012770
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VOSOL HC acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 012770 NDA ECR Pharmaceuticals Co., Inc. 0095-0201 0095-0201-10 1 BOTTLE, DROPPER in 1 CARTON (0095-0201-10) > 10 mL in 1 BOTTLE, DROPPER
VOSOL HC acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 012770 NDA Hi-Tech Pharmacal Co., Inc. 50383-901 50383-901-10 1 BOTTLE, DROPPER in 1 CARTON (50383-901-10) > 10 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OTICStrength2%;1%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Argus Health
US Department of Justice

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