Esclim

   
Google
 
Web NewDrugInformation.com

Esclim


Drug - Esclim
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 - 0.1MG/24HR
The potency of the active ingredient(s), Estradiol. May repeat for multiple part products.

Applicant - WOMEN FIRST HLTHCARE
The firm name holding legal responsibility for Esclim. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020847
The FDA assigned number to Esclim. Format is nnnnnn.

Product Number - 005
The FDA assigned number to identify Esclim. 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 4, 1998
The date Esclim 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 Esclim. 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 Esclim is in. Format is RX, OTC, DISCN.

Applicant Full Name - Women First Healthcare Inc
The full name of the firm holding legal responsibility for the new application of Esclim.

Esclim