Azulfidine

   
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Azulfidine


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

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

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

Strength - 250MG/5ML
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. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 086983
The FDA assigned number to Azulfidine. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Azulfidine. 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 Azulfidine 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. 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 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.

Azulfidine