Fosamax

   
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Fosamax


Drug - Fosamax
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
Multiple ingredients are in alphabetical order.

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

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

New Drug Application (NDA) Number - 020560
The FDA assigned number to Fosamax. Format is nnnnnn.

Product Number - 005
The FDA assigned number to identify Fosamax. 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 - Oct 20, 2000
The date Fosamax 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. 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 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.

Fosamax