Suprax

   
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Suprax


Drug - Suprax
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) - Cefixime
Multiple ingredients are in alphabetical order.

Strength - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
The potency of the active ingredient(s), Cefixime. May repeat for multiple part products.

Applicant - LEDERLE
The firm name holding legal responsibility for Suprax. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 050621
The FDA assigned number to Suprax. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Suprax. 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 - Apr 28, 1989
The date Suprax 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 Suprax. 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 Suprax is in. Format is RX, OTC, DISCN.

Applicant Full Name - Lederle Laboratories Div American Cyanamid Co
The full name of the firm holding legal responsibility for the new application of Suprax.

Suprax