Fosamax Plus D

   
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Fosamax Plus D


Drug - Fosamax Plus D
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) - Alendronate Sodium; Cholecalciferol
Multiple ingredients are in alphabetical order.

Strength - EQ 70MG BASE;2,800 IU
The potency of the active ingredient(s), Alendronate Sodium; Cholecalciferol. May repeat for multiple part products.

Applicant - MERCK
The firm name holding legal responsibility for Fosamax Plus D. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021762
The FDA assigned number to Fosamax Plus D. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Fosamax Plus D. 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 - Apr 7, 2005
The date Fosamax Plus D 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 Fosamax Plus D. 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 Fosamax Plus D is in. Format is RX, OTC, DISCN.

Applicant Full Name - Merck And Co Inc
The full name of the firm holding legal responsibility for the new application of Fosamax Plus D.

Fosamax Plus D