Flecainide Acetate

   
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Flecainide Acetate


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

Strength - 100MG
The potency of the active ingredient(s), Flecainide Acetate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 075882
The FDA assigned number to Flecainide Acetate. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Flecainide 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 - Oct 28, 2002
The date Flecainide 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 Flecainide 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 Flecainide 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 Flecainide Acetate.

Flecainide Acetate