Vosol Hc

   
Google
 
Web NewDrugInformation.com

Vosol Hc


Drug - Vosol Hc
The trade name of the product as shown on the labeling.

Dosage - SOLUTION/DROPS; OTIC
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Acetic Acid, Glacial; Hydrocortisone
Multiple ingredients are in alphabetical order.

Strength - 2%;1%
The potency of the active ingredient(s), Acetic Acid, Glacial; Hydrocortisone. May repeat for multiple part products.

Applicant - MEDPOINTE PHARM HLC
The firm name holding legal responsibility for Vosol Hc. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 012770
The FDA assigned number to Vosol Hc. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Vosol Hc. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AT
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Approved Prior to Jan 1, 1982
The date Vosol Hc was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - Yes
The pioneer or innovator of Vosol Hc. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Vosol Hc is in. Format is RX, OTC, DISCN.

Applicant Full Name - Medpointe Pharmaceuticals Medpointe Healthcare Inc
The full name of the firm holding legal responsibility for the new application of Vosol Hc.

Vosol Hc