Vivelle

   
Google
 
Web NewDrugInformation.com

Vivelle


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

Dosage - FILM, EXTENDED RELEASE; TRANSDERMAL
The product dosage form and route separated by a semi-colon.

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

Strength - 0.0375MG/24HR
The potency of the active ingredient(s), Estradiol. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020323
The FDA assigned number to Vivelle. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Vivelle. 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 28, 1994
The date Vivelle 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 Vivelle. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Vivelle is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Vivelle.

Vivelle