Boniva

   
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Boniva


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

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

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

Strength - EQ 2.5MG BASE
The potency of the active ingredient(s), Ibandronate Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021455
The FDA assigned number to Boniva. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Boniva. 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 - May 16, 2003
The date Boniva 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 Boniva. 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 Boniva is in. Format is RX, OTC, DISCN.

Applicant Full Name - Hoffmann La Roche Inc
The full name of the firm holding legal responsibility for the new application of Boniva.

Boniva