Femtrace

   
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Femtrace


Drug - Femtrace
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) - Estradiol Acetate
Multiple ingredients are in alphabetical order.

Strength - 0.45MG
The potency of the active ingredient(s), Estradiol Acetate. May repeat for multiple part products.

Applicant - WARNER CHILCOTT
The firm name holding legal responsibility for Femtrace. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021633
The FDA assigned number to Femtrace. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Femtrace. 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 20, 2004
The date Femtrace 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 Femtrace. 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 Femtrace is in. Format is RX, OTC, DISCN.

Applicant Full Name - Warner Chilcott Inc
The full name of the firm holding legal responsibility for the new application of Femtrace.

Femtrace