Fludrocortisone Acetate

   
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Fludrocortisone Acetate


Drug - Fludrocortisone 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) - Fludrocortisone Acetate
Multiple ingredients are in alphabetical order.

Strength - 0.1MG
The potency of the active ingredient(s), Fludrocortisone Acetate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 040425
The FDA assigned number to Fludrocortisone Acetate. Format is nnnnnn.

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

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

Approval Date - Jan 21, 2003
The date Fludrocortisone 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 Fludrocortisone Acetate. 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 Fludrocortisone Acetate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Barr Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Fludrocortisone Acetate.

Fludrocortisone Acetate