Cortisone Acetate

   
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Cortisone Acetate


Drug - Cortisone Acetate
The trade name of the product as shown on the labeling.

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Cortisone Acetate
Multiple ingredients are in alphabetical order.

Strength - 25MG
The potency of the active ingredient(s), Cortisone Acetate. May repeat for multiple part products.

Applicant - IVAX PHARMS
The firm name holding legal responsibility for Cortisone Acetate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 083536
The FDA assigned number to Cortisone Acetate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Cortisone Acetate. 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 - Approved Prior to Jan 1, 1982
The date Cortisone Acetate 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 Cortisone Acetate. 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 Cortisone Acetate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ivax Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Cortisone Acetate.

Cortisone Acetate