Hydrocortisone And Acetic Acid

   
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Hydrocortisone And Acetic Acid


Drug - Hydrocortisone And Acetic Acid
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 - BAUSCH AND LOMB
The firm name holding legal responsibility for Hydrocortisone And Acetic Acid. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 040097
The FDA assigned number to Hydrocortisone And Acetic Acid. Format is nnnnnn.

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

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

Approval Date - Oct 31, 1994
The date Hydrocortisone And Acetic Acid 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) - No
The pioneer or innovator of Hydrocortisone And Acetic Acid. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Hydrocortisone And Acetic Acid is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bausch And Lomb Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Hydrocortisone And Acetic Acid.

Hydrocortisone And Acetic Acid