Azulfidine En-tabs

   
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Azulfidine En-tabs


Drug - Azulfidine En-tabs
The trade name of the product as shown on the labeling.

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

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

Strength - 500MG
The potency of the active ingredient(s), Sulfasalazine. May repeat for multiple part products.

Applicant - PHARMACIA AND UPJOHN
The firm name holding legal responsibility for Azulfidine En-tabs. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 007073
The FDA assigned number to Azulfidine En-tabs. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Azulfidine En-tabs. 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 - Apr 6, 1983
The date Azulfidine En-tabs 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) - Yes
The pioneer or innovator of Azulfidine En-tabs. 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 Azulfidine En-tabs is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pharmacia And Upjohn Co
The full name of the firm holding legal responsibility for the new application of Azulfidine En-tabs.

Azulfidine En-tabs