Vagifem

   
Google
 
Web NewDrugInformation.com

Vagifem


Drug - Vagifem
The trade name of the product as shown on the labeling.

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

Active Ingredient(s) - Estradiol
Multiple ingredients are in alphabetical order.

Strength - 25UGM
The potency of the active ingredient(s), Estradiol. May repeat for multiple part products.

Applicant - NOVO NORDISK INC
The firm name holding legal responsibility for Vagifem. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020908
The FDA assigned number to Vagifem. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Vagifem. 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 26, 1999
The date Vagifem 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 Vagifem. 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 Vagifem is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novo Nordisk Inc
The full name of the firm holding legal responsibility for the new application of Vagifem.

Vagifem