Actonel With Calcium (copackaged)

   
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Actonel With Calcium (copackaged)


Drug - Actonel With Calcium (copackaged)
The trade name of the product as shown on the labeling.

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

Active Ingredient(s) - Calcium Carbonate; Risedronate Sodium
Multiple ingredients are in alphabetical order.

Strength - EQ 500MG BASE,N/A;N/A,35MG
The potency of the active ingredient(s), Calcium Carbonate; Risedronate Sodium. May repeat for multiple part products.

Applicant - PROCTER AND GAMBLE
The firm name holding legal responsibility for Actonel With Calcium (copackaged). The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021823
The FDA assigned number to Actonel With Calcium (copackaged). Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Actonel With Calcium (copackaged). 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 12, 2005
The date Actonel With Calcium (copackaged) 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 Actonel With Calcium (copackaged). 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 With Calcium (copackaged) is in. Format is RX, OTC, DISCN.

Applicant Full Name - Procter And Gamble Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Actonel With Calcium (copackaged).

Actonel With Calcium (copackaged)