Eligard

   
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Eligard


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

Dosage - INJECTABLE; SUBCUTANEOUS
The product dosage form and route separated by a semi-colon.

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

Strength - 30MG/VIAL
The potency of the active ingredient(s), Leuprolide Acetate. May repeat for multiple part products.

Applicant - QLT USA
The firm name holding legal responsibility for Eligard. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021488
The FDA assigned number to Eligard. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Eligard. 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 - Feb 13, 2003
The date Eligard 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 Eligard. 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 Eligard is in. Format is RX, OTC, DISCN.

Applicant Full Name - Qlt Usa Inc
The full name of the firm holding legal responsibility for the new application of Eligard.

Eligard