Estradiol

   
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Estradiol


Drug - Estradiol
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
Multiple ingredients are in alphabetical order.

Strength - 1MG
The potency of the active ingredient(s), Estradiol. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 040275
The FDA assigned number to Estradiol. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Estradiol. 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 - Dec 29, 1998
The date Estradiol 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 Estradiol. 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 Estradiol is in. Format is RX, OTC, DISCN.

Applicant Full Name - Clonmel Healthcare Ltd
The full name of the firm holding legal responsibility for the new application of Estradiol.

Estradiol