Actonel
Drug - Actonel
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) -
Risedronate Sodium
Multiple ingredients are in alphabetical order.
Strength -
30MG
The potency of the active ingredient(s), Risedronate Sodium. May repeat for multiple part products.
Applicant -
PROCTER AND GAMBLE
The firm name holding legal responsibility for Actonel. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020835
The FDA assigned number to Actonel. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Actonel. 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 -
Mar 27, 1998
The date Actonel 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) -
No
The pioneer or innovator of Actonel. 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 Actonel 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 Actonel.
Actonel
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