Asacol

   
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Asacol


Drug - Asacol
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) - Mesalamine
Multiple ingredients are in alphabetical order.

Strength - 400MG
The potency of the active ingredient(s), Mesalamine. May repeat for multiple part products.

Applicant - PROCTER AND GAMBLE
The firm name holding legal responsibility for Asacol. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019651
The FDA assigned number to Asacol. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Asacol. 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 - Jan 31, 1992
The date Asacol 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 Asacol. 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 Asacol is in. Format is RX, OTC, DISCN.

Applicant Full Name - Procter And Gamble Pharmaceuticals Inc Sub Procter And Gamble Co
The full name of the firm holding legal responsibility for the new application of Asacol.

Asacol