Drug - Ibu-tab
The trade name of the product as shown on the labeling.
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Multiple ingredients are in alphabetical order.
The potency of the active ingredient(s), Ibuprofen. May repeat for multiple part products.
The firm name holding legal responsibility for Ibu-tab. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
The FDA assigned number to Ibu-tab. Format is nnnnnn.
Product Number -
The FDA assigned number to identify Ibu-tab. 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 -
Aug 11, 1988
The date Ibu-tab 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) -
The pioneer or innovator of Ibu-tab. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
The group or category of approved drugs Ibu-tab is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Alra Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Ibu-tab.