Didronel

   
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Didronel


Drug - Didronel
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) - Etidronate Disodium
Multiple ingredients are in alphabetical order.

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

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

New Drug Application (NDA) Number - 017831
The FDA assigned number to Didronel. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Didronel. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Approved Prior to Jan 1, 1982
The date Didronel 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 Didronel. 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 Didronel 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 Didronel.

Didronel