Paser

   
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Paser


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

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

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

Strength - 4GM/PACKET
The potency of the active ingredient(s), Aminosalicylic Acid. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 074346
The FDA assigned number to Paser. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Paser. 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 - Jun 30, 1994
The date Paser 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 Paser. 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 Paser is in. Format is RX, OTC, DISCN.

Applicant Full Name - Jacobus Pharmaceutical Co
The full name of the firm holding legal responsibility for the new application of Paser.

Paser